GAMP jobs in Massachusetts

Hybrid in Cambridge, Massachusetts

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Today

Duration: 9 months Pay: $70-93/hr. Location: Hybrid - Cambridge, MA (Mostly remote; preference for local candidates able to be onsite 2 days/month as needed. Fully remote considered.)The Senior Clinical Systems Analyst will serve as the primary liaison between end users and the clinical data warehouse implementation team, supporting the adoption of clinical technologies that improve trial management, data review, and analysis. This role will focus initially on the implementation and adoption of

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Contract

BASED ON EXPERIENCE

GxP Instrument Systems Engineer

Marlborough, Massachusetts

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Today

TITLE- - GxP Instrument Systems Engineer / Senior Project Engineer Location - Ability to be on-site 3-4 days/week between Marlborough, MA and Norwood, MA locations Long Term Contract 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. Job Responsibiliti

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Contract, Third Party

$market rate

Lead Solutions Engineer

Remote or Addison, Texas

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Today

RESPONSIBILITIES: Kforce is working with a client in search of a Lead Solutions Engineer to join their team in Addison, TX. Summary: We are seeking a Lead Solutions Engineer to spearhead the technical design and delivery of end-to-end systems within a regulated software environment. This is a newly created role within our Biomass and Software organization, offering the opportunity to shape a high-impact project from the ground up. Duties Include: * Lead the technical design and integration of

Full-time

$120,000 - $180,000 annually

GxP Instrument Systems Engineer

Hybrid in Norwood, Massachusetts

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5d ago

Position: GxP Instrument Systems Engineer Location: Norwood, MA (Hybrid Model) Job Type: Contract long-term Job Description: The GxP Instrument Systems Engineer / Senior Project Engineer will lead the design, deployment, and management of automation and digital enterprise instrumentation systems supporting Quality Control laboratories and integration with connected digital platforms. Required Qualifications: Bachelor s degree in science, engineering, or computer science (or equivalent).5 7+ year

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Contract, Third Party

Depends on Experience

Controls Engineer

Wilmington, Massachusetts

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Today

Title: Controls Engineer Location : Wilmington, MA Target Start Date : ASAP Type: Direct Hire, Full Time Salary : $110-120K plus uncapped bonus (paid 3x/year) Our client, a Top 5 Systems Integrator and industry leader in automation & controls space, is seeking an experienced Controls Engineer to design, program, and implement advanced control systems for industrial processes and machinery. This role involves full project lifecycle execution-from system architecture design through programming,

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Full-time

USD 110,000.00 - 120,000.00 per year

Benchling Validation Consultant

Remote

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8d ago

Benchling Validation Consultant KEY RESPONSIBILITIES: Strong understanding of CSA (Computer Software Assurance) In-depth knowledge of GAMP 5, 21 CFR Part 11, and Annex 11 compliance requirements Hands-on experience with Benchling cloud-based LIMS platform Validation efforts for periodic SaaS/cloud releases, patches, upgrades, and enhancements Assess GxP impact of each release and update validation deliverables accordingly. Develop Validation Plans that align with the platform s release cycle and

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Contract

$90 - $100

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

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

Computer System Validation - CSV Engineer

Remote or New Jersey

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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

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

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

Senior Validation Engineer

Lexington, Massachusetts

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Today

Responsibilities: Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; Write and execute qualification protocols for new equipment and decommissioning protocols for old equipment. Execute approved protocols per company Good Documentation Practices (cGDP

Full-time

Computer System Validation (CSV) Engineer

Remote or Massachusetts

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Today

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree

Full-time

SAP Validation consultant Remote Location

Remote

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8d ago

King of Prussia PA Job Description: >> 12+ years Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems >> Perform review for GxP systems to ensure compliance with regulatory requirements >> Working knowledge on end-to-end validation of GxP applications and is able to perform documentprocess Compliance Analysis >> Adept with Agile and Waterfall methodology-based software development Compliance a

Contract, Third Party

$70 - $70

R&D Business Systems Lead (BSA/PM) with Life Sciences -GxP Expereince

Remote

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3d ago

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: R&D Business Systems Lead (BSA/PM) Location: Cambridge, MA (Remote) Duration: 12+ months Qualifications & Experience Required: 8+ years of combined experience in Life Sciences IT, including:Minimum 4 years in a GxP-regulated system administrator or support capacity.Minimum 4 years in project management, delivering cross-functional systems in R&D or Clinical domains.Str

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Contract

Depends on Experience

Automation Engineer

Hybrid in Medford, Massachusetts

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10d ago

Automation Engineer IV Location: Medford, MA (Hybrid 3 days onsite / 2 days remote)Salary: $135,000 $175,000 Overview We are seeking an experienced Automation Engineer IV to design and implement automation strategies for large, complex projects in the life sciences, biotech, and pharmaceutical sectors. This role involves collaborating with mechanical and process teams, developing specifications for BAS vendors, and ensuring compliance with GMP standards. Key Responsibilities Develop control stra

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Full-time

$135,000 - $170,000

SDMS Validation Engineer

Remote

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15d ago

Role: Scientific Data Management System (SDMS) Validation Engineer Location: NEAR SHORE - South America/Canada Length: Long term rolling contract CSV engineers and for the applications: Discoverant, BIOVIA ELN, SDMS, Empower, LabX, SoftMax Pro. Job Description: Job Overview: The SDMS (Scientific Data Management System) Validation Engineer is responsible for the qualification, validation, and compliance of scientific data management systems within laboratory environments, particularly in regula

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Contract

$30 - $35

Commercialization & Validation Engineer

Remote or Hybrid

•

Today

The CSA Validation SME is a key stakeholder within the ELC CSA Center of Excellence (COE). This role ensures the integrity of CSA projects with a strong focus on risk assessment, compliance, and regulatory adherence. Acting as a subject matter expert (SME), the CSA Validation SME serves as a bridge between COE leadership, protocol authors, and testers. The SME will ensure projects meet regulatory, data integrity, and organizational (R&D/GSC/IT) policies while maintaining best practices in valida

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Contract

$70 - $75 per hour

Technical Lead Oracle EPM (GAAP Workstream)

Remote

•

Yesterday

Job Title: Technical Lead Oracle EPM (GAAP Workstream) Location: Denver, CO; Cedar Rapids, IA; or Philadelphia, PA (preferred); (Remote is okay for the right candidate)Duration: 6 Month Contract (Likely Extensions as this is a 2-3 year program) Key Responsibilities: Lead the GAAP workstream supporting the transition from IFRS17 to U.S. GAAP, ensuring alignment with the Oracle EPM implementation timeline and architecture. Collaborate with finance, compliance, and technology teams to define and e

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Contract, Third Party

Depends on Experience

Technical Lead Oracle ERP (GAAP Workstream)

Remote

•

Yesterday

Position: Technical Lead Oracle ERP (GAAP Workstream) Location: Denver, CO; Cedar Rapids, IA; or Philadelphia, PA (preferred); Remote is okay for the right candidate Duration: 6 Month Contract (Likely Extensions as this is a 2-3 year program) Key Responsibilities: Lead the GAAP workstream within the Oracle Cloud Financials ERP program, ensuring alignment with the overall implementation strategy and timeline. Collaborate with finance, compliance, and technology teams to define and execute the tr

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Contract, Third Party

Depends on Experience

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GAMP jobs in Massachusetts, USA