GAMP jobs in Massachusetts

Tewksbury, Massachusetts

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Title: Technical Support Specialist II Location: United States Position Summary: Join our ambitious team at Thermo Fisher Scientific Inc. as a Technical Support Specialist II! In this customer service role, you will provide outstanding support to our customers, ensuring a flawless experience through timely troubleshooting and resolution of complex technical issues. You will collaborate with Field Service

Full-time

USD 32.00 - 43.00 per hour

Controls Engineer

Billerica, Massachusetts

•

Yesterday

Location: Billerica, MA Salary: $100,000.00 USD Annually - $120,000.00 USD Annually Description: Judge Direct Placement is seeking an Instrumentation & Controls Engineer for a national Engineering solutions client in the Boston suburbs! Responsibilities: Assist in design and troubleshooting of Instrumentation Controls systems for all mechanical and electrical issues including but not limited to PLCs, various motion controls, multi-axis servos, SCADA systems, AC/DC drives, electronics, PLC t

Contract

USD 100,000.00 - 120,000.00 per year

Controls Engineer

Wilmington, Massachusetts

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4d ago

Full Time Role Please share Profiles at Hi, Urgent need, Controls Engineer Wilmington, MA JOB DESCRIPTION: We have a Controls Engineering position available in our Wilmington, MA office.This person will support controls engineering project requirements involving PLC programming, DCS programming, HMI/SCADA programming, database management, control panel design, instrumentation specification, engineering documentation support, check-out support and commissioning assistance.*Job Descriptions are n

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Full-time

$100,000 - $120,000

Operational Data Hub Engineer

Needham, Massachusetts

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23d ago

Title: Operational Data Hub (ODH) Engineer Regulatory Relevance: GxP The Role: Moderna is seeking a Principal Engineer, Data Systems to drive the evaluation, design, and delivery of the digital manufacturing data management technologies globally. The individual will lead strategic projects, evaluations, and customizations of the digital manufacturing systems. Activities will also include cross training of other digital manufacturing engineers. Key Responsibilities of the Position: List the Key R

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Contract, Third Party

$60 - $70

MES Engineer

Remote or Needham, Massachusetts

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12d ago

Title: MES Technical Consultant Regulatory Relevance: GxP The Role: The MES Technical Consultant will serve a key role owning the development and validation of core MES recipe objects and accompanying integrations. Additionally, this individual will also be well versed in Infobatch report development, web development, SQL, ISA S-95 standards will be act as an escalation point contact for the MES, Infobatch and ODH teams for complex initiatives. Key Responsibilities: Lead the design, development,

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Full-time, Third Party

$60 - $70

Computer System Assurance

Remote

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26d ago

Location Remote (USA) Must Have Skills: Proven experience in CSA and GAMP 5 implementation.RTM configuration in any ALM tool, exposure to the Veeva CMS tools, need to have CSM admin experience.Strong knowledge of Veeva validation management and a basic understanding of Veeva configurations.Excellent analytical and problem-solving skills.Strong verbal and written communication abilities.Demonstrated ability to work effectively with global, virtual teams.Experience working independently, guiding

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Contract

$45+

Controls Engineer (DeltaV)

Remote

•

Today

Title: Controls Engineer (DeltaV) Location : Remote - but must be in the Kalamazoo, MI area Target Start Date : ASAP Type: Direct Hire Salary : $120-160K (DOE) plus uncapped bonus Our client, a Top 5 systems integrator for automation & controls systems with over 40 years of experience, is seeking an experienced Controls Engineer to design, configure, and implement Emerson DeltaV automation solutions, primarily for life sciences and other process manufacturing industries. This role involves deliv

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Full-time

USD 120,000.00 - 160,000.00 per year

CSA Auditor, TraceLink

Remote

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11d ago

We are seeking a Computerized System Assurance (CSA) Auditor with deep experience in TraceLink and GxP-regulated environments to ensure the compliance, validation, and lifecycle integrity of computerized systems supporting serialization, traceability, and supply chain management. This role is critical in evaluating vendors, systems, and processes to meet FDA, EMA, and global regulatory expectations for data integrity and system validation. Key Responsibilities: Plan, conduct, and report CSA aud

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Contract

85 - 90

Sr. IT Program Manager

Remote or Massachusetts

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Uncover a remarkable opportunity at Thermo Fisher Scientific Inc. to push global advancements in health, cleanliness, and safety as a Sr. IT Program Manager in Waltham. Become a part of our elite team, guiding ambitious IT projects that enhance quality, compliance, and supply chain operations within our Contract Development and Manufacturing Organization (CDMO). Argument Development & Case Creation Collaborate

Full-time

Staff Engineer - Software Quality - Indianola, Pa (Hybrid)

Remote or Indianola, Pennsylvania

•

Today

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of br

Full-time

USD 97,264.00 - 145,897.00 per year

Validation Engineer 3 - R&D

Bedford, Massachusetts

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Today

Work Location: Bedford, Massachusetts Shift: No Department: LS-PS-RVCN NFF & SU Chrom Validation Recruiter: Beverly Dellisola This information is for internals only. Please do not share outside of the organization. Your Role: MilliporeSigma in Bedford, MA is seeking a Validation Engineer 3. As a member of the R&D Validation & Applications Center (VAC) Engineering team, you will actively participate on filtration product development teams to understand the new product and its applications. You

Full-time

USD 80,400.00 - 140,300.00 per year

IT CSV & CQV Validation Lead

Boston, Massachusetts

•

Today

Responsibilities: Documentation & Deliverables: Develop and author comprehensive validation and quality documentation, including protocols, reports, risk assessments, SOPs, and other project-related materials. Ensure all documentation complies with applicable regulatory standards such as FDA, EMA, GxP, and other relevant guidelines. Review and approve validation documents to confirm alignment with both project objectives and regulatory requirements. Project Management: Lead and oversee multiple

Full-time

Senior CSV Engineer

Remote or Massachusetts

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Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

Validation Engineer II

Remote or Durham, North Carolina

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Today

Job Description Summary The Validation Engineer II, assists with the authoring, executing and reviewing of SOP's, commissioning documentation, documents required for validation/qualification. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsibilities:

Full-time

USD 70,000.00 - 130,000.00 per year

CSV and Validation Engineer

Remote or New Jersey

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Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

GXP Instrument Systems Engineer

Norwood, Massachusetts

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Today

Job Description: The qualified GxP Instrument Systems Engineer / Senior Project Engineer will be responsible for the design, deployment and management of automation and digital enterprise instrumentation systems that support Quality Control laboratories and system integration with connected Digital platforms. Responsibilities: Collaborate with Business Analysts and Software/Automation Engineers in the complete product lifecycle management of Digital Quality Automation Systems (Hamilton Venus, W

Full-time

IT CSV Engineer

Boston, Massachusetts

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Today

Responsibilities: Works with the project team to author qualification deliverables such as Infrastructure/Network specifications, Qualification Protocols, Test Cases, Risk Assessments, and Summary Reports. Develop system development life cycle documents related to site infrastructure. This includes system specification documents, qualification plans and test protocols, and procedures. Coordinate qualification activities, propose and implement qualification strategies. Support the operational tea

Full-time

Computer System Validation - CSV Engineer

Remote or New Jersey

•

Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

Director - Lab Informatics

Remote

•

Yesterday

Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, increase operational efficiency, and ensure regulatory complianc

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Contract, Third Party

Director, Lab Informatics

Remote

•

Yesterday

Director, Lab Informatics Job Location- Remote Long Term Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, incre

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Full-time, Part-time, Third Party, Contract

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GAMP jobs in Massachusetts, USA