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Regulatory Affairs Specialist--Temporary 12 Months (Remote)
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JOIN A TEAM COMMITTED TO IMPROVING PATIENT CARE It takes a team of talented people to become one of the world's leading providers of innovative medical devices. AngioDynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated technologies that address unmet patient needs and supporting professional healthcare providers around the world in the delivery of high-quality patient care.We accomplish this through: A Commitment to the Highest Standards of Quality Relentless Innovation Operational Excellence Our employees receive the highest level of training and endeavor to be the best and the brightest in the medical device industry. We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families. 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May perform other duties as assigned Regulatory Responsibilities Manages in order to ensure compliance with all relevant regulatory/legal requirements. Quality Systems Duties and Responsibilities Build Quality into all aspects of their work by maintaining compliance to all quality requirements Education and Experience Bachelors Level of Degree in a scientific or technical discipline field of study Equivalent work related experience acceptable in lieu of degree 1-2+years of experience in Regulatory Affairs supporting EU MDR/International registrations. Medical industry experience required. Skills/Knowledge Experience in the following computer software applications: Microsoft Office General understanding of product development process and design control. Effective written and oral communication, technical writing and editing skills. Effective research and analytical skills. Ability to work independently with minimal supervision. Working knowledge of FDA and international regulations. 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While performing the duties of this job: § Work safely and follow all OSHA regulations and company safety policies and procedures. § For all on-the-job injuries or accidents, must notify manager/supervisor immediately. § Exposure to standard office environment § Ability to frequently lift and/or move up to 15 lbs § Ability to occasionally lift and/or move up to 50lbs § Ability to regularly sit or stand for extended periods of time This position requires some travel up to 5% of the time All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other legally protected status. The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. AngioDynamics does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract. Your ultimate salary may vary depending on your job-related skills, knowledge, and experience.
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ModernaTX, Inc., Marlborough
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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. Here's What You'll Bring to the Table:A 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 Engineering or Chemical EngineeringMinimum of 3 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) -
FIeld Engineer (HVAC)
The TJX Companies, Inc., Marlborough
Field EngineerThe Opportunity: Contribute To The Growth Of Your Career. Directly supports HVAC Engineering Manager. Travels to stores to perform on-site inspections, provide problem resolution for HVAC equipment malfunctions and coordinate equipment replacement for all domestic TJX chains. Contributes on all aspects of mechanical engineering of existing stores, including design, re-engineering, scope of work development, HVAC equipment & vendor sourcing and project supervision. Makes decisions related to when and how HVAC equipment should be replaced and oversees projects from start to finish. Prioritizes projects based on estimated life, cost of repairs, availability of parts, energy efficiency, lease terms, etc. equipment, BAS, roofing systems. Use HVAC experience to assist team with troubleshooting, root cause analysis and repair suggestions as required for all domestic TJX chains. Assists with the resolution of all building problems of a mechanical and technical nature that are escalated from Energy Management, Energy Services and Facilities departments. Supports Manager of HVAC Engineering develop specifications for HVAC equipment and EMS systems.Responsibilities:Key contributor for TJX's national roof top unit (RTU) replacement programTravels to stores to perform on-site inspections, provide problem resolution for equipment malfunctions and coordinate equipment repair/replacementDetermine the condition of existing equipment to make recommendations on equipment replacementsContributes to develop annual and long term forecast capital budgets for replacement of HVAC equipmentAssigning projects to regional HVAC install vendors and oversees projects from inception to completionResolves escalated HVAC/mechanical issues from various Property Development partnersProvides support and guidance for HVAC vendor selection and evaluation of vendor performanceWorks directly with national HVAC equipment manufacturesContributes to develop specifications for HVAC equipment RFP/RFIWho We Are Looking For: You. Bachelor's degree, (Engineering degree preferred) or equivalent HVAC work experience10 years of HVAC related experienceAdvanced knowledge of HVAC equipment and Building Controls systemsStrong project management skills for multi-site retail environmentWorking knowledge for budget forecastingWorking knowledge of building structural requirements with regard to HVAC equipment replacementStrong understanding of ductwork design and air side troubleshootingStrong knowledge of reading mechanical and controls drawingsStrong communication skills (written and verbal)Strong analytic and mechanical problem-solving skillsAgile mindset, ability to multitask in a fast paced environmentExperience with national account HVAC equipment manufacturers National multi-site vendor management experienceMicrosoft 365 suite proficiency, including ExcelExperience with Service Channel platform a plusWillingness to travel up to 20% of time as needed across the eastern portion of the USWe care about our culture, but we also prioritize your needs! Benefits include Associate discount; 401(k) match; medical/dental/vision; HSA; health care FSA; life insurance; short/long-term disability; paid holidays/vacation /sick/bereavement/parental leave; EAP; incentive programs for management; auto/home insurance discounts; tuition reimbursement; scholarship program; adoption/surrogacy assistance; smoking cessation; child care/cell phone discounts; pet/legal insurance; credit union; referral bonuses. All benefits are subject to applicable plan or program terms (including eligibility terms) and may change from time to time. Contact your TJX representative for more information.This position has a starting salary range of $80,500 to $102,700 per year.Actual starting pay is determined by a number of factors, including relevant skills, qualification and experience.