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Project Specialist Salary in Waltham, MA

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Agile Project Manager

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Applications Manager

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Applications Project Manager

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Architect Project Manager

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Assistant Project Manager

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Associate Project Manager

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Business Project Manager

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Capital Project Manager

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Clinical Project Manager

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Customer Project Manager

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Design Project Manager

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Digital Project Manager

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Electrical Project Manager

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Facilities Project Manager

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Finance Project Manager

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General Project Manager

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Global Project Manager

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Healthcare Project Manager

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Implementation Project Manager

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Infrastructure Project Manager

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International Project Manager

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Marketing Project Manager

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Principal Project Manager

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Program Coordinator

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Project Assistant

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Project Control Manager

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Project Controls Manager

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Project Coordinator

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Project Integrator

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Project Management Consultant

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Project Manager

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Project Officer

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Security Project Manager

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Software Project Manager

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Support Project Manager

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Systems Project Manager

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Technical Project Manager

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Technology Project Manager

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Testing Project Manager

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Training Project Manager

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Utilities Project Manager

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Quality & Compliance Specialist, RN
Mass General Brigham Healthcare at Home, Waltham
Mass General Brigham Home Care, an affiliate of Mass General Brigham, is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve. At Mass General Brigham, we believe in equal access to quality care, employment and advancement opportunities encompassing the full spectrum of human diversity: race, gender identity, sexual orientation, ability, religion, ethnicity, national origin and all the other forms of human presence and expression that make us better able to provide innovative and cutting-edge healthcare and research.DescriptionMass General Brigham Home Care serves patients from rehabilitation after illness or injury, to chronic disease management. We are dedicated to providing the highest quality specialized care designed to meet the patients' unique needs with the goal of optimizing independence and quality of life. Our clinicians are highly skilled and able to function both independently and as part of an interdisciplinary team.We value the uniqueness of our employees who are a reflection of the communities and patients that we serve. Our attractive and comprehensive benefits package is designed to meet the needs of our employees.Qualifications Job SummaryOversight of quality and compliance programs in assigned region. Perform quality reviews ensuring clinical documentation is comprehensive so as to provide a high quality of patient care, along with ensuring that documentation is in compliance with regulatory requirements for a home health agency. Manage and process quality and compliance issues through resolution. Manage assigned quality and compliance projects.Key Activities• Oversight of quality and compliance trends, issues and resolutions• Identify improvement opportunities and assist in development of improvement plan• Assume leadership role as expert resource in at least one area of quality and compliance, staying abreast of new developments and keeping department members and the organization informed• Manage record requests, subpoenas, interactions and communications with regulatory officials as it relates to region specific requests and needs.• Work closely with other staff members to ensure that quality and compliance standards are adhered to.Qualifications and Experience• Current Massachusetts license as a registered nurse or rehab therapist• Minimum 2 years clinical experience in a home health environment• Familiarity with clinical documentation requirements in home health environment• Computer literate with working knowledge of Microsoft Office and ability to learn a variety of other software applications• Ability to travel throughout eastern Massachusetts within Mass General Brigham geographic regions• Previous medical records review experience preferred• Ability to develop and maintain strong working relationships with clinical managers• Strong organizational and communications skills. Ability to interpret and analyze data• Ability to manage projects independently and assume responsibility for successful completion• Operate with integrity, honesty and objectivityEEO Statement Mass General Brigham Home Care is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Accounts Payable Specialist
Beacon Hill Staffing Group, LLC, Waltham
Accounts Payable SpecialistOur client, a printing manufacturing company, is looking to hire an Accounts Payable Specialist to join their team! This role will be onsite at the Waltham location and estimated to be around 3-6 months long. Qualified candidates will have 3+ years of relevant experience & the ability to work onsite.Responsibilities:Process daily invoicesResearch and reconcile account discrepanciesCheck the AP inboxAnswer any AP emails- customer service Assist with expenses when needed Assist with month end when neededAssist with monthly adhoc projectsBeacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.Company Profile: Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com . We look forward to working with you.Beacon Hill. Employing the Future™
Data Integration Specialist
Bentley University, Waltham
Job Description SummaryAs a Data Integration Specialist, you will be responsible for daily operational work, such as reviewing and resolving tickets involving database and/or integration tasks. Your primary focus will be to support and enhance our data management and application ecosystem, collaborating with cross-functional teams to implement efficient API integrations, troubleshoot issues, and maintain data integrity.Essential Duties:Plan and apply Oracle and/or Microsoft SQL server security patches.Troubleshooting and issue resolution: identify and resolve integration, application, and database related issues promptly to minimize downtime and maintain a high level of system availability.Provide support for emergency and urgent requests during business hours as well as non-business hours.Daily operational task including, but not limited to creating users and assigning appropriate roles and permissions, execute SQL queries, compiling scripts, monitoring, and researching security tickets.Data mapping and transformation: Work closely with business analysts and other SMEs to map data fields, perform data transformations, and ensure data accuracy across different systems.Performance monitoring and optimization: Monitor integration performance metrics and proactively optimize integration processes to enhance overall system efficiency.Documentation and reporting: Maintain comprehensive documentation of application and integration processes, changes, and issues. Generate regular reports to communicate status and performance to stakeholders.Collaboration and communication: Collaborate with IT team members, business application owners, and external partners to facilitate smooth integration of various systems and data sources.Software and DB maintenance: Research, install, configure, and test software & database including database modifications, security modifications, overseeing testing through implementation.Design and implement API integrations: develop, test (including participation in code review sessions) and deploy API-based integrations between internal and external systems, ensuring smooth data flow and efficient communication.Other Duties:Stay abreast of technology trends: Continuously research and evaluate emerging integration technologies, best practices, and industry trends to propose improvements and optimize integration strategies set for by our enterprise solutions architect.Training and knowledge sharing: Participate in training sessions and knowledge-sharing activities with team members and end-users to improve integration understanding and usage across the organization.Cross-functional support: Provide support to other IT and business teams on integration related matters and assist in resolving integration challenges across various projects.Maintain direct contact with vendors for product announcements, upgrades, and installations.Minimum Qualifications:Bachelor’s degree in computer science, Information Technology, or a related field.A minimum of 3 years of experience in designing and implementing API integrations in an enterprise environment.Proficiency in working with RESTful APIs, SOAP services, and other integration protocols.Strong critical thinking skills and the ability to troubleshoot and resolve complex integration issues.Solid understanding of data mapping, transformation, and data validation techniques.Possess strong knowledge of Oracle and SQL Server support tools and advanced SQL exposure and optimization techniques.Excellent communication and collaboration skills to work effectively with cross functional teams.Familiarity with security principles and best practices related to integration processes.Ability to work independently, prioritize tasks, and meet project deadlines.Typical office setting with extensive sitting and computer work. Flexible work schedule including ability to work remotely.Ability to travel around campus for meetings and other work-related events.Preferred Qualifications:Experience with data warehouse platforms such as Microsoft Synapse.Experience supporting SaaS solutions such as Workday, PowerFAIDS, Slate, Millennium, and Infor.Familiarity with integration platforms and tools such as Snaplogic, Informatica, and Azure Logic AppsKnowledge of various data formats, including XML, JSON, and CSV.Understanding of enterprise application architectures and database technologies and SQL for data retrieval and manipulation.Experience with version control systems, such as Git or Azure DevOpsWork EnvironmentTypical office setting with extensive sitting and computer workAbility to travel around campus for meetings and other work related eventsBentley University requires references checks and may conduct other pre-employment screening.DIVERSITY STATEMENTBentley University strives to create a campus community that welcomes the exchange of ideas, and fosters a culture that values differences and views them as a strength in our community.Bentley University is an Equal Opportunity Employer, building strength through diversity. The University is committed to building a community of talented students, faculty and staff who reflect the diversity of global business. We strongly encourage applications from persons from underrepresented groups, individuals with disabilities, covered veterans and those with diverse experiences and backgrounds.PI240476086
Quality System Specialist
GForce Life Sciences, Waltham
Internal Title: Quality Systems SpecialistDuration: 8-month contract Location: Hybrid - Waltham, MA (Onsite Tues, Wed, Thurs)Responsibilities: Assist in the governance of Quality System applications, including harmonization of processes across sitesAssist in gathering requirements for improvements and ongoing maintenance by participating in meetings/workshops with Site Process Owners and business SMEsParticipate in additional user forums for gathering ongoing requirements and prioritization and triage issuesFollow-up on requests, issues, and projects and report statuses to manager/ working teamsInitiate and manage change controls, with associated documentation requirements, to completionEnsure the system is maintained in a validated state by participating in periodic user access reviews, ongoing change management, business administration, and deviations/CAPAs associated with Quality SystemsSupport validation activities as requested; this includes but is not limited to requirements gathering, validation planning, design qualification, authoring test plans, and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reportsQualifications: Bachelor's degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality backgroundMinimum of 3-6 years of experience in a high-volume commercial/clinical pharma/healthcare facilityProficient in MS Word, Excel, and Quality System processes. Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus.Understanding and working knowledge of US FDA and European regulatory requirements and GMP, and the ability to determine phase-appropriate requirementsKnowledge of Regulatory Compliance and ICH Guidelines
Implementation and Quality Improvement Specialist
The Baker Center for Children and Families, Waltham
Implementation and Quality Improvement Specialist The Baker Center for Children and Families (aka: Judge Baker Children's Center), a Harvard Medical School affiliate, is seeking a full-time Implementation & Quality Improvement Specialist to work with our Quality Care Initiative team. This is an exciting opportunity to work with an expert group of professionals dedicated to improving the quality of behavioral health care and social services for children and families. The primary responsibility of the Implementation Specialist will be to collaborate with the Quality Care Initiative team to carry out an array of activities, including implementation and quality improvement activities, project management, and communication between project staff, trainers, and community partners receiving training and/or technical assistance. In addition, the Implementation Specialist will have opportunities to work on a variety of projects, develop reports and dashboards, create survey tools and databases, and critically analyze quantitative and qualitative data. We are looking for a mission-driven individual who possesses excellent interpersonal and communication skills and is comfortable collaborating with a range of professionals. They will have expertise in fields of public health and/or macro-level social work, and have skills related to project management, data analysis, and organizational consultation. A strong interest in behavioral health services and child welfare are preferred. The Implementation Specialist will be responsible for strategic planning and content development for various trainings, toolkits, and related materials for clients, providers, policy-makers, and other implementation partners. The Implementation Specialist will report directly to the Director of Implementation and Quality Improvement. The Implementation Specialist will work within Baker Center's Quality Care Initiative (QCI). The QCI works to create lasting improvements in the quality of behavioral health care and other services for all children and families by facilitating the adoption, implementation, and sustainability of evidence-based practices in community settings. Our expert staff works collaboratively with families, service providers, schools, state agencies, academic institutions, and funding organizations to help ensure that all children and families have access to the highest quality care. Our approach focuses on translating the most cutting-edge research and proven strategies for helping children and families into sustainable practice changes in real world settings. By using thoughtful, evidence-informed, and carefully planned implementation strategies, we work to close the research-to-practice gap. Essential Duties and Responsibilities Manage implementation and quality improvement activities, meetings, trainings, and other activities supporting the work of the department. Work closely with Baker Center staff, subcontractors, and training consultants to ensure that all quality improvement deliverables are met and are on time. Lead 1:1 and small group consultation calls, partner meetings, and multidisciplinary work groups. Manage and support data systems development and maintenance, quantitative data collection, management, and reporting of both process and outcome data. Utilize qualitative methods, such as focus groups and interviews, synthesize themes, and develop recommendations. Collaborate directly with staff from state agencies and/or behavioral health providers to deliver consultation through in-person site visits, one-on-one calls, and conference calls. Develop and disseminate implementation and quality improvement strategies and activities for identified initiatives including both internal and external projects to Baker Center. Conduct ad hoc research for quality improvement and implementation projects and respond to collaborator requests for data. Participate in off-site meetings with external partners. Assist with other aspects of quality improvement including administrative and operational support as needed. Qualifications and Skills Possess at least a Master's Degree in macro social work, public health, health administration, organizational behavior or closely related field with concentration in Behavioral Health, Implementation Science, and/or Quality Improvement strongly preferred. Requires at least two-years' of experience with project management and implementation or quality improvement. Ability to utilize implementation, quality improvement, and/or public health methodologies and frameworks (i.e. PDSA, CFIR, Needs Assessments). Experience and comfort with public speaking and presenting information to a wide range of stakeholders and leadership Ability to conduct data analysis, develop data reports, develop and manage database systems and dashboards, and utilize survey tools. Knowledge of the mental health, education, child welfare, and/or juvenile justice systems. Possess excellent interpersonal and communication skills and be comfortable collaborating with a range of professionals. Proficient with Microsoft Office (Word, Excel, PowerPoint, SharePoint) and project management platforms (.e.g, Asana, Monday.com)). Proficiency with SPSS, SAS, or some other statistical analysis software is required. Ability to manage multiple assignments and complete assignments independently. Must be extremely organized, efficient, adaptive, and a good team player that likes to work in a collaborative environment.Physical Requirements (With or without accommodation)Must be able to climb, balance, stoop, kneel, crouch, crawl, reach, stand, walk, push, pull, lift, finger, grasp, feel, talk, hear and be capable of repetitive motion. Position requires exerting up to 20 pounds of force occasionally and/or 10 pounds of force frequently, and/or negligible amount of force constantly. Work requires close visual acuity. Position is not substantially exposed to adverse environmental conditions. EXEMPT/NON-EXEMPT: Exempt/SalaryFULL-TIME/PART-TIME: Full-TimeSALARY: $70,000-85,000OPEN DATE: Ongoing until filled.SCHEDULE: Eligible for flexibility with a hybrid work model, combining onsite (Waltham) and remote work OR fully remote ApplicationsInterested applicants should attach: a cover letter specifically addressing your experience related to the job responsibilities above, A curriculum vitae or resume, and a writing sampleProfessional references may be requested.PI241201583
Sales Analyst
Constant Contact, Waltham
Do you thrive in a fast-paced, analytical environment where innovation, excellence and creating actionable insight are not just catch-phrases but steeped in the company's culture? We seek an analyst with a strong intellect, even stronger curiosity, and an experienced problem solver who can drive business value by proactively recognizing needs, connecting the dots, and turning it into actionable insights and recommendations. Working across nearly all parts of Constant Contact, the Analytics team is on a journey to develop a deep understanding of our customers across all aspects of their lifecycle leveraging internal and 3rd party data. The group also focuses on internal performance optimization.We seek a Sales Analyst with strong analytical and problem solving skills that has business curiosity.  Serving an array of business stakeholders across the organization, the Analyst will conduct and analyze data on customer acquisition, sales lifecycle, and financial impact. As a part of cross-functional teams (e.g Sales, Marketers, Finance) you will be responsible for uncovering paths to customer acquisition via sales motions that improve sales performance at the intersection of marketing, revenue, and sales.What you'll do:Collaborate with Sales, Marketing, Finance, Product, and other internal stakeholders to identify opportunities for analysis and optimization the sales experience to acquire and retain valuable customersProvide insights into prospective customer behavior and sales engagement to the rest of the businessPartner closely with the data warehouse and revenue operations teams to understand data availability and the flow of data through various systemsConduct analysis of prospects and customers for sales motion design, go-to-market strategies, and financial impact effortsDevelop data inquiries, and conduct data exploration and data mining to determine program effectiveness and predict future performancePartner closely with business stakeholders to ensure insights are leading to action and measuring the business impactWho you are:Ability to be in-office 2 days a week at our Waltham locationBachelor's degree (preferably in a quantitative field such as business, math, statistics, or computer science)1 - 3  year of experience in a corporate environment conducting analytical analyses in a business setting and telling stories with dataMust be results driven, and take appropriate steps to achieve goals while taking ownership of situations as neededMust have excellent organizational skills, strong attention to detail and ability to effectively manage projects supporting multiple business partnersResourceful and a motivated problem solver. You enjoy and have demonstrated ability tackling complex problems, drawing inferences from data, and using your analysis skills and business acumen to identify solutions.Strong experience with SQL and ExcelPrior experience with data visualization tools (Tableau, PowerBI, etc.)Strong communication skills. An ability to talk both to the technical teams responsible for the data and comfortable explaining data and conclusions to non-technical teamsPrior experience with Python and/or R a plusPrior experience with Salesforce a plus
Project Analyst Senior
Proclinical Staffing, Waltham
Project Analyst Senior - Contract - Waltham, MAProclinical is seeking a dedicated and experienced Senior Project Analyst. This is a contract position located in Waltham, MA.Primary Responsibilities:This role focuses on leading small projects or supporting large programs within the facilities management sector, particularly for a new R&D lab/office site. The successful candidate will collaborate with cross-functional teams to align project goals with operational needs and ensure a seamless transition from project phase to operational phase.Skills & Requirements:Bachelor's degree in facilities management, business administration, engineering, or a related field.Certification in project management, such as PMP, is highly desirable.Experience in facilities management, in a lab environment.Experience with commissioning and operational readiness processes.Strong project management skills, including planning and scheduling for complex projects.Proficiency in project management software.Excellent communication and interpersonal skills.Exceptional organization and time management skills.Attention to detail and a commitment to accuracy.Ability to work well under pressure and adapt to changing priorities.Strong leadership skills with the ability to influence to achieve project goals.In-depth knowledge of hard services, including HVAC, electrical, plumbing, and building management systems.Ability to work independently and collaboratively in a team-oriented environment.The Sr. Project Analyst will:Oversee the planning, execution, and delivery of facilities management services.Collaborate with construction, engineering, and facilities teams to align project goals with operational needs.Manage and coordinate maintenance, utilities, and infrastructure systems.Develop and implement facilities services readiness plans.Monitor project progress, identify potential issues, and implement corrective actions.Ensure compliance with all relevant health, safety, and environmental regulations.Provide regular updates and reports to senior management and stakeholders.Develop scope for third-party service providers.Compensation:$45 - $52 per hourIf you are having difficulty in applying or if you have any questions, please contact Kylie Williams at (+1) 267-523-2542 or [email protected] is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.Proclinical Staffing is an equal opportunity employer.
Protection Engineering Specialist
firstPRO, Inc, Waltham
This can encompass a range of duties including coordination studies, fault studies, relay settings, disturbance investigations, protection reviews and repair, safety implementation and monitoring and participation in small and large scale engineering projects. At the higher levels this role will also develop protection policy, complex protection system design, complex disturbance investigations, audit support, protection industry committee participation. Provide protection designs that ensure effective operations and ensure other business units are provided with the appropriate technical expertise to meet local needs.Key Accountabilities:• Provide protection design and perform coordination and short circuit engineering studies, analysis and disturbance investigations, under supervision, in order to recommend corrective action in problem areas, or to prevent problems.• Independently collate and analyze data using ASPEN, WaveWin, symmetrical components, and manufacturer equipment software in order to support the department's decision making process.• Execute instructions and requests, plan and organize resources and make appropriate arrangements to ensure that work is carried out efficiently and in line with relevant policies and processes.• Test and challenge existing procedures and highlight areas for improvement in order to ensure they are robust.• Develop relationships with internal and external stakeholders in order to obtain and share information that will benefit our organization.• Undertake specific tasks of varying complexity in order to support colleagues in the design of technical solutions.• Build upon technical/professional skills within own area of specialism or of other processes in order to continually grow your personal contribution to the business.
Validation Engineer (CSV)
GQR, Waltham
Title: Validation Engineer (CSV)Location: Waltham, MAStatus: 6-month contractHourly rate: $60Please note that this role is not able to provide sponsorship or work on a C2C basis.Position Overview:The Computer System Validation Specialist will support the validation activities for computer systems and computerized equipment, ensuring compliance with policies and procedures. This role encompasses both local and global enterprise systems, as well as SaaS (Software as a Service) solutions, and reports to the Manager of Validation.Key Responsibilities:Conduct validation activities, including requirements gathering, validation planning, design qualification, test plan and script creation, test script execution, discrepancy management, and preparation of system descriptions and validation summary reports.Perform system-based risk assessments to determine GxP applicability, assess associated risks, and define validation activities based on risk levels.Assist the Validation Team with all aspects of the computer system and computerized equipment lifecycle during projects and operational phases, including the development, review, and execution of validation documentation.Provide validation support during the operational phase by conducting change impact assessments, determining required testing levels, authoring and executing test scripts related to changes, and preparing change qualification reports.Support periodic reviews of computer systems and user access reviews for computerized equipment.Assist in the business administration of the electronic validation lifecycle management system (ValGenesis).Train end users on the ValGenesis system.Manage and update validation templates in ValGenesis.Qualifications:Bachelor's degree in a Science or Engineering discipline.Minimum of 5 years of relevant experience in computer system validation.Experience with computer systems supporting R&D functions such as Clinical, Pharmacovigilance/Drug Safety, Medical Affairs, Supply Chain, Regulatory Affairs, and Quality Assurance is advantageous.Familiarity with ValGenesis is a plus.Practical experience with quality risk management and risk-based validation approaches.Knowledge of cGMP regulations and guidelines, including U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9, and Q10.Understanding of industry standards and best practices for computer system validation, such as GAMP 5 and ASTM E2500.Skills and Abilities:Ability to objectively review and make judgments within the wider context of quality and compliance.Strong troubleshooting skills.Effective collaboration and teamwork with cross-functional teams.Capability to manage a high volume of simultaneous projects and validation activities.This role is critical in maintaining the integrity and compliance of computer systems and ensuring they meet regulatory standards and internal policies.
CSV/ Validation Engineer
Beacon Hill Staffing Group., Waltham
Beacon Hill Life Sciences is partnering with a Biotechnology company in the Boston area who are seeking a CSV/Validation Engineer to join their team. This is a contract through the end of the year and will be hybrid- must be able to commute on-site to Waltham, MA 2-3 days per week. KEY AREAS OF JOB ACCOUNTABILITY: The holder of this position is charged with supporting computer system/computerised equipment validation activities and ensuring compliance with company policies and procedures. Position scope includes local and global enterprise systems as well as SaaS (Software as a Service) solutions. This role will report into the Manager of Validation.Perform validation activities supporting requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports.Perform system-based risk assessments in determining GxP applicability of the system, associated risk and resulting validation activities per risk.Support Validation Team on all aspects of the computer system/computerised equipment lifecycle during projects and operational phase, including but not limited to development, review and execution of validation documentation.Provide validation support during the operational phase by performing change impact assessments, determine the required level of testing, authoring and executing test scripts related to the change and change qualification report.Support periodic review of computer systems.Support periodic user access review of computer systems/computerised equipments.Support business administration of the electronic system (ValGenesis) used for validation lifecycle management.Support training of end users on the electronic system (ValGenesis) used for validation lifecycle management.Support management of Validation Templates in ValGenesis in terms of authoring/updating templates.ACADEMIC/TECHNICAL QUALIFICATIONS:Bachelor's degree in a Science or Engineering discipline required5+ years relevant experience in computer system validation.SPECIALIST/TECHNICAL QUALIFICATIONS/KNOWLEDGE:Experience computer systems supporting R&D functions like Clinical, Pharmacovigilance/Drug Safety, Medical Affairs, Supply Chain, Regulatory Affairs and Quality Assurance is a plusExperience with ValGenesis is a plusPractical experience with quality risk management and risk-based validation approaches.Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10. Understanding of industry standards and best practices for computer system validation such as GAMP 5 and ASTM E2500ABILITIES AND JUDGEMENT:? Ability to objectively review.? Ability to make judgements in the wider context of quality/compliance? Ability to perform effective trouble shooting? Ability to collaborate and work with cross-functional teams? Ability to manage high volume of simultaneous projects/validation activitiesRelocation is not approved for this posting. This is a hybrid position.Please apply with your updated resume and contact information to be considered. Thank you for your time and interest!