Manufacturing/Mechanical Salary in Marlborough, MA

The Foreman/ Site Manager will be responsible for:Maintaining site excavationSupervising a crew, ensuring productivity, quality, and safety of a projectIn depth knowledge of construction procedures, equipment operation, and current OSHA safety standardsAbility to read drawings, plans, and engineering specificationsPerform quantity takeoff, order all materialsScheduling trucking needs, equipment, and fuel with internal managers and third party vendorsSchedule and oversee subcontractors, on site vendors, and police detailsReview monthly schedule updates and provide one week look ahead details to company leadershipMonitor stagings ares and ensure property maintenance (erosion control, dust control, soil, etc)MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The Foreman/ Site Manager will have:The ideal candidate will have a minimum of 5 - 10 years of experience with site grading, digging and removal of earth, installation of utilities and foundations, drainage and storm water managementValid MA Driver's license with a clean recordDOT Certificate (acquired within one month after date of hire)Hoisting License 2A/1CExperience with determining grade heights, utilities, lasers, reading plansComfortable working in a team environmentExcellent organizational, time management, and leadership skillsAbility to proactively plan and take initiativeNice to have: ability to train new workersNice to have: ability to run excavation machinery to assist as needed in the execution of work

Join our Engineering team at Helen of Troy and make an immediate impact on our trusted brands: OXO, Hydro Flask, Osprey, Honeywell , PUR , Braun , Vicks , Hot Tools , Drybar , Curlsmith , and Revlon . Together, we build innovative and useful products that elevate people's lives everywhere every day.Look around your home, and you'll find us everywhere, in your kitchen, living room, bedroom, and bathroom. We are already making your everyday lives better. We are powered by knowledgeable, enthusiastic, and forward-thinking people committed to developing a culture of inclusion. Whether you are just starting your career or in need of a challenge, we recognize, develop, and empower talent!Position: Program ManagerDepartment: Engineering, Beauty & WellnessWork Location: Marlborough, MA, Hybrid (work 3 days onsite)Hybrid Schedule: Helen of Troy associates enjoy the advantages and flexibility of a hybrid working model, allowing for in office 3 days minimum, and remote 2 days. Any changes to this working model would be communicated accordingly.What you will be doing:Manage projects ranging from simple changes to full product development for the Beauty & Wellness business unit. The ideal candidate will have demonstrated experience managing products ranging from portable consumer home appliances to Class I and Class II consumer medical and diagnostics devices.Take a lead role in planning, schedule development, setup, and execution of key programs, working closely with marketing, finance, sourcing, regulatory and manufacturing functions.Provide leadership daily, effectively communicate project plans, schedules, costs, and risks to both working teams and management.Serve as an active problem solver during execution of the programs and have the ability to determine and implement risk mitigation plans.Keep multiple program schedules and budgets up to date, report status of projects per requirements.Responsible for supporting ongoing technical feasibility efforts, performance and/or clinical validations, and cost reductions.Provide technical mentorship to teams to conduct design reviews.Develop and maintain accurate Design History Files to meet regulatory submissions and audit requirements.Skills needed to be successful in this role:Ability to balance multiple projects and remain flexible and adaptableAbility to collaborate with multiple global vendors to coordinate activity and track commitments, and in general lead all aspects of the delivery of quality products on schedule and within budgetAble to handle a diverse team and work with team members and suppliers across different countries and time zonesPossess the leadership, project management and teamwork skills vital to interact with a multi-functional distributed team and advise them in achieving assigned goals and objectivesDemonstrated delivery of projects within budget and schedule constraints in a fast-paced environmentStrong attention to detail and a demonstrated ability to work independentlyStrong communication skills including ability to provide concise and accurate status of projects on a weekly basisProven capabilities in identifying issues, assessing technical and project alternatives and risks, and implementing solutions while keeping projects on track.Proven track record in project management, demonstrating strong organizational skillsMinimum Qualifications:Bachelor's degree in Mechanical Engineering, Electrical Engineering, or similar1+ years experience working in consumer goods, medical, or any equivalent regulated industryExpertise in program management of multiple projects on a global basisSolid understanding of ETL, UL, FDA, ISO 13485, process validation, design history files, and international regulatory specifications and requirementsUnderstanding small devices' design, manufacturing and other practices including plastic design, molding, and electrical/medical devicesProficient in Microsoft Office and Microsoft ProjectAuthorized to work in the United States on a full-time basisPreferred Qualifications:Smartsheet experienceBenefits: Salary + Bonus, Healthcare, Dental, Vision, Paid Holidays, Paid Parental Leave, 401(k) with company match, Basic Life Insurance, Short Term Disability (STD), Long Term Disability (LTD), Paid Time Off (PTO), Paid Charitable (volunteer) Leave, and Educational Assistance.Wondering if you should apply? Helen of Troy welcomes people as diverse as our brands! Have the confidence to come as who you are because your point of view, skills, and experience will make us stronger. If you're eager to share new ideas and try new things, we want to hear from you.#LI-EB1#LI-HYBRIDFor more information about Helen of Troy, visit www.helenoftroy.com . You can also find us on LinkedIn , Glassdoor , Facebook , Instagram and Twitter . Helen of Troy is an Equal Opportunity/Affirmative Action Employer. We are committed to developing a diverse workforce and cultivating an inclusive environment. We value diversity and believe that we are strengthened by the differences in our experiences, thinking, culture and background. We do not discriminate on the basis of race, color, religion, sex, national origin, sexual orientation, gender identity, age, marital status, disability, protected veteran status or any protected basis. We will provide individuals with disabilities reasonable accommodation to participate in the job application process. If you would like to request an accommodation, please contact Human Resources at (915) 225-8000. Founded in 1968, Helen of Troy is a prominent player in the global consumer products industry, offering diverse career opportunities across North America, South America, Europe, and Asia. We boast a collection of renowned brands such as OXO®, Hydro Flask®, Osprey®, Honeywell®, PUR®, Braun®, Vicks®, Hot Tools®, and Drybar® - many of which rank #1, #2, or #3 in their respective categories, making the Helen of Troy name synonymous with excellence and ingenuity.At Helen of Troy, our strategy involves acquiring brands that we can integrate and enhance, amplifying their unique attributes to drive growth and profitability. Embracing a culture of collaboration internally and externally, we are committed to providing innovative solutions tailored to consumers, operational excellence, global scalability, and exceptional shared services to support our brand portfolio. This dedication to fostering development and success sets Helen of Troy apart as a pioneer in the industry, propelling our brands to unparalleled heights of success and recognition worldwide. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and duties required of personnel so classified. Management retains the right to add or to change duties of the position at any time.

The RoleThe senior maintenance manager is a part of our Marlborough, MA INT team will be a leader in our pharmaceutical environment, with a focus on energy management, reliability, and team performance. They are responsible for overseeing and managing the maintenance, calibration and operation of utility and process systems critical to pharmaceutical manufacturing processes. They play a crucial role in optimizing energy usage, ensuring reliable functioning of equipment and systems, and must foster a high-performing team. The senior manager leads a team of technicians, coordinates maintenance activities, manages service providers, develops energy management strategies, and implements initiatives to enhance reliability and team performance.Here's What You'll DoLead, manage, and train a team of maintenance technicians in a pharmaceutical environment, focusing on reliability, performance management, and compliance with Good Manufacturing Practices (GMP).Develop and implement maintenance strategies for process and utility systems, coordinate maintenance activities, and conduct regular inspections to optimize performance, reliability, and compliance with regulatory requirements.Manage service agreements and vendors to ensure safe and compliant execution of maintenance and calibrations.Oversee complex troubleshooting and repairs on equipment, analyze system performance data, and implement improvements to enhance efficiency and reduce downtime.Collaborate with other departments and external vendors for scheduling repairs, maintenance, and upgrades, manage the maintenance budget effectively, and maintain accurate records of all activities.Ensure adherence to safety regulations, environmental standards, and other applicable industry-specific regulations while prioritizing reliability and performance optimization initiatives.Additional duties as may be assigned from time to timeHere's What You'll Bring to the Table:Bachelor's degree in engineering, facilities management, or a related field is preferred. Equivalent experience and certifications may be considered.Minimum of 10 years of experience in utility maintenance, with a significant portion of that experience in a fast-paced pharmaceutical environment, with a focus on reliability and performance management.In-depth knowledge of utility systems specific to the pharmaceutical industry, including HVAC, electrical, plumbing, and mechanical systems, with a strong understanding of GMP guidelines and regulatory requirements, and a proven track record in reliability and performance improvement in a fast-paced setting.Strong troubleshooting and problem-solving skills, with the ability to analyze complex issues and develop effective solutions while maintaining compliance with GMP guidelines and regulatory requirements, with a focus on reliability and performance enhancement in a fast-paced environment.Proficient in reading and interpreting technical manuals, blueprints, and schematics specific to pharmaceutical utility systems.Ability to work in a fast-paced, high-pressure environment.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-NB1-

The RoleIn this role, you will be responsible for HVAC, GMP Facilities and Grey Utilities engineering and maintenance and Moderna's Manufacturing Building in Marlborough, MA. You will be the subject matter expert for Utility Systems throughout construction and will work directly with CQV team members to ensure that all commissioning and qualification efforts are coordinated with full knowledge and understanding of the utilities supporting each activity onsite. This position will provide engineering support for all site utilities and will lead investigations for any non-conformance events along side the Quality, IT and Manufacturing teams.Here's What You'll DoThe Plant Engineer will participate on project teams through all phases of engineering projects in the HVAC and utility areas including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.Collaborate effectively with Construction Team, CQV Team and Moderna End Users throughout each phase of construction to ensure proper turnover of systems, utilities, equipment and all associated documentation. Owner of the GMP utility and HVAC equipment and systems at the Marlborough site to include troubleshooting equipment to determine root cause of failure modes, owning Corrective/Preventative Actions and associated change controls, providing input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.Systems include but are not limited to; WFI, RODI, Compressed Air, Process Air, Nitrogen, Vacuum and HVAC. Provide a high level of customer support to the Facilities and Manufacturing teams, the Plant Engineer must develop a deep knowledge of the utility and HVAC requirements of each of the manufacturing areas.Troubleshoot and investigate system trends and alarms through use of BMS and CMS systems.The Plant Engineer must work in a safe manner at all times by adhering to all safety procedures and have a proactive safety mindset.Generate, review, and maintain lifecycle documentation associated with all systems from construction through daily operations. QualificationsA key requirement of this position is the ability to collaborate with cross-functional stakeholders to determine the best path forward to identified issues by balancing technical, compliance, and business objectives.The Plant Engineer needs to be able to drive results by owning and completing the subsequent projects including high quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted.BS in Mechanical EngineeringMinimum of five years professional experience required in engineering, facilities or operations.Familiarity with biotechnology operations, including GMP labs.Knowledge of cleanroom design, GMP HVAC and GMP utilitiesExcellent interpersonal and communication skills (verbal and written) are required.Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions.Technical writing skills required.Must be able use his/her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions.Must be able to be able to find true root cause and path forward for complex problems.Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.Additional duties as may be assigned from time to timeA desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-NB1-

The RoleThe electrical technician in the pharmaceutical industry is responsible for ensuring the safe and efficient operation of electrical systems and equipment within a our manufacturing facility. They play a crucial role in maintaining electrical infrastructure, troubleshooting electrical issues, and performing preventive maintenance to minimize downtime and ensure compliance with regulatory requirements. The electrical technician works closely with the maintenance team and other departments to support pharmaceutical production processes.Here's What You'll DoInstall, maintain, and repair electrical systems and equipment in accordance with electrical codes, safety regulations, and Good Manufacturing Practices (GMP) specific to the pharmaceutical industry.Conduct routine inspections of electrical systems to identify potential issues, malfunctions, or safety hazards and take appropriate corrective actions.Troubleshoot electrical problems, diagnose faults, and perform repairs to restore equipment functionality and minimize production downtime.Perform preventive maintenance tasks on electrical systems and equipment, including testing, calibration, and replacement of components as necessary.Collaborate with other maintenance technicians and engineers to plan and execute electrical maintenance activities, ensuring minimal disruption to pharmaceutical production processes.Assist in the installation and commissioning of new electrical systems and equipment, ensuring compliance with specifications and safety standards.Maintain accurate records of maintenance activities, including work orders, equipment history, and inventory of electrical components and spare parts.Follow safety protocols and procedures, including lockout/tagout, to ensure a safe working environment and prevent accidents or injuries.Stay updated with the latest electrical codes, regulations, and industry best practices relevant to the pharmaceutical industry.Duties as may be assigned from time to time.Here's What You'll Bring to the Table:High school diploma or equivalent; additional technical certifications or vocational training is preferred.Military training equivalent of above is acceptable.High school diploma or equivalent. Completion of an electrical trade school program or apprenticeship is preferred.Proven experience as an electrical technician, preferably in a pharmaceutical or manufacturing environment.In-depth knowledge of electrical systems, including power distribution, control panels, motors, lighting, and instrumentation.Familiarity with electrical codes, safety regulations, and GMP guidelines specific to the pharmaceutical industry.Proficient in reading and interpreting electrical schematics, blueprints, and technical manuals.Strong troubleshooting skills and the ability to diagnose and repair electrical faults efficiently.Experience with electrical testing equipment, such as multimeters, oscilloscopes, and insulation testers.Minimum of 7 years of proven experience in maintaining and troubleshooting electrical systems.Preferred 5 years of proven experience in maintaining systems in a pharmaceutical or similar regulated environment.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-NB1-

The RoleModerna is looking for a Senior Specialist, Quality Control Bioassay for their Marlborough, MA facility. This role entails supporting cGMP-compliant Bioassay methods, including transfer, qualification, validation, and release testing of raw materials, plasmids, cell stocks, drug substances, and finished products for mRNA therapies manufactured at Moderna. Additionally, the specialist will take part in non-testing projects and tasks as required.Here's What You'll DoConduct molecular and protein analytics testing, utilizing various methodologies as necessary.Facilitate testing of in-process samples, drug substances, and products to produce data for commercial products.Aid in developing and maintaining lab operations in line with cGMP standards.Perform routine lab support tasks, such as preparing reagents and maintaining equipment.Write and revise SOPs, protocols, and reports.Assist with quality systems records such as deviations, change controls, CAPAs as required. Establish and maintain a safe laboratory working environment Provide support to audit teams for internal and vendor audits. Here's What You'll Bring to the Table:BS in a relevant scientific discipline with a minimum of 6-8 years (or MS in a relevant scientific discipline with 4 years) Quality Control experience in a cGMP organization Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations Knowledge and hands-on experience performing and troubleshooting assays such as Sequencing, electrophoresis, PCR, Residual Protein Assays, and Cell Culture Excellent troubleshooting skills and the ability to concisely communicate scientific issues. Proven ability to conduct investigations.Familiarity with electronic databases (e.g. LIMS, SAP, LMS, or equivalent software).Strong written and oral communication skills as well as organizational skills. Ability to efficiently and independently prioritize, manage and complete multiple projects and tasks in a fast-paced environment. Desired Attributes:Ability to work collaboratively across departments. Commitment to safety and quality. Vision for continuous improvement and innovation. Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -

My client seeks a highly motivated Director of Regulatory Affairs to join their growing organization. In this role, you will be responsible for all activities to lead and maintain global regulatory approvals to market devices throughout the product development lifecycle while building and managing a regulatory team.Responsibilities:Develop strategies for regulatory approval of medical devices worldwide based on business needs.Organize project teams, initiate project schedules, and provide project leadership worldwide to achieve desired regulatory outcomes within defined timeframes.Prepare global regulatory applications, including US medical submissions (pre-submissions, 510ks, IDEs, and annual reports) and EU MDR, and design dossiers and technical files for other international markets.Interact with the US FDA and other regulatory authorities worldwide.Manage reporting to the FDA (MDRs) and Vigilance Reports; participate in the Complaint System.Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.Participate in Risk Management assessments.Review design and manufacturing changes for compliance with applicable regulations.Oversee and prepare documentation to support the Clinical Evaluation Report to ensure accuracy, applicability, consistency, and control of regulatory documents.Support quality system audits by notified bodies, government agencies, and customers.Assist with environmental regulations and standards (e.g., RoHS, REACH, etc.).Hire, mentor, and train regulatory staff; engage outside contractors as needed.Perform all other essential duties as assigned.Requirements:Must have experience with Class II programmable electro-mechanical and sterile medical devices.Bachelor's degree, preferably in an engineering or life sciences discipline, advanced degree preferred.10+ years of regulatory experience with US and international submissions.Demonstrated aptitude for preparing and submitting 510(k)'s and international design dossiers for new products.Medical Laser experience preferred.Prior interaction with the FDA and other worldwide agencies is required.Hands-on knowledge of all phases of Design Controls and Risk Management practices, regulations and standards, including FDA QSR's, ISO 13485, 14971, 10993, 11607, 14644, 14698, 15223, 11135, 11138, 11737, 17665, and 22442, and IEC 60601, 60825, 62304, and 62366.Experience in building and managing regulatory teams and leading cross-functional project teams on collaborative projects.Strong working knowledge of Microsoft Word and Excel.

The RoleIn this role, this candidate will be responsible for cGMP compliance of computer system validation of process, facility, utilities, equipment, method and will be accountable for their execution in Moderna's Individualized Neoantigen Therapy program.Here's What You'll DoReview and audit computerized system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirementsReview validation documentation - such as user requirements, functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, test scripts, trace matrix requirements, deviations, validation summary reports, decommissioning reports and system use documentation (system admin, user admin procedures)Work with manufacturing/engineering to ensure necessary compliance controls are in place for computer system design changes/enhancementResponsible for QA oversight of the development and implementation of Quality, manufacturing, and laboratory systems/processes to facilitate new projects and continuous improvement activitiesCollaborate with global, cross-functional teams to accomplish company objectives and team goals, including but not limited to, on-time completion of system go-lives and enhancements With Manager support and guidance, identify and implement continuous improvement efforts for the computerized systems validation program to ensure alignment with regulatory regulations/guidance as well as Moderna mindsetsProvide support for GxP regulatory inspections, as needed, including acting as subject matter expert for Quality GxP computer validation topicsMonitor industry, new/revised regulations around CSV and guidance for impact to the organization related to computer system validationReview and approve deviations / OOS records and CAPAs Review and approve change control and IT/Digital Change Control records Review and approve Periodic Reviews for Computer SystemsFollow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.Here's What You'll Need (Minimum Qualifications)Education: Bachelor's in science/EngineeringExperience: B.S. degree (engineering or scientific discipline) with at 6+ years' experience OR Master's degree with 2-5 years' experienceHere's What You'll Bring to the Table (Preferred Qualifications)Experience in QA and/or Validation in the pharmaceutical industry.Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -