OQ jobs in Boston, MA

Boston, Massachusetts

•

Today

Responsibilities: Generate, execute, review, finalize, and approve validation/qualification protocols and reports. Manage and update project validation plans for specific projects. ssist and deliver amendments to the qualification(s) to ensure qualification compliance within agreed upon timelines. Utilize computerized asset management system for managing validation/qualification schedules. Generate operational and maintenance SOPs, FATs, URSs, FRSs, validation protocols and reports. Requirements

Full-time

Validation Engineer 2 - R&D

Bedford, Massachusetts

•

Today

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious mind

Full-time

USD 80,400.00 - 140,300.00 per year

Validation Engineer 3 - R&D

Bedford, Massachusetts

•

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

Supplier Engineer II

Danvers, Massachusetts

•

Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

USD 79,000.00 - 127,650.00 per year

Senior Supplier Engineer

Remote or Danvers, Massachusetts

•

Today

Full-time

USD 91,000.00 - 147,200.00 per year

GMP & GxP Business Analyst

Remote

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18d ago

GMP & GxP Business AnalystLocation: RemoteDuration: Long Term Roles & ResponsibilitiesGather, analyze, and document business and user requirements across functional teams.Act as the primary liaison between Business, IT, end users, and cross-functional stakeholders during project execution and maintenance phases.Analyze business challenges and support evaluation of appropriate IT solutions.Collaborate with managers and end users to ensure alignment and buy-in for proposed solutions.Develop detail

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Contract

Depends on Experience

SAP PPQM PTS Consultant Remote

Remote or Atlanta, Georgia

•

Yesterday

Job Id: #CGEMJP00321513 Title: SAP PPQM PTS Consultant Location: Remote Duration: 12+ Months Position Summary: Job Role and Responsibilities: We are looking for a highly skilled Senior SAP PPQM Consultant with over 6 years of experience in SAP Production Planning (PP) and Quality Management (QM) modules, specifically within the pharmaceutical industry. The ideal candidate will have a deep understanding of GxP compliance, regulatory requirements, and validation documentation. This role involv

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

CSV and Validation Engineer

Remote or New Jersey

•

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

Senior CSV Engineer

Remote or Massachusetts

•

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 III

Remote or Durham, North Carolina

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Today

Job Description Summary The Validation Engineer , is responsible for authoring, executing and reviewing/approval 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. Responsi

Full-time

USD 89,600.00 - 166,400.00 per year

Sr Process Engineer

Danvers, Massachusetts

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Today

Job Description: Process Technologies: Lead the exploration and development of new process technologies that may be incorporated into new product development projects or existing manufacturing lines. Analysis provided is in-depth in nature and often provides recommendations on process improvements. Process Development: Lead new product development by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality, cost effective pro

Full-time

Field Service Engineer II

Remote or Raleigh, North Carolina

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Laboratory Setting, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biolog

Full-time

Senior QAV Specialist

Bedford, Massachusetts

•

Today

A recognized pharma company in Massachusetts is actively seeking a new Senior QAV Specialist for a one-year contract near Bedford, MA. About the Opportunity: Schedule: Monday to Friday Hours: Standard business Setting: Onsite Responsibilities: Review and approval of analytical instrument qualification (AIQ) protocols, reports, validation issues, specifications and assessments Review and approval of periodic reviews for manufacturing Review and approval of data integrity assessments and audit t

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Contract

$74 - $74 per hour

Senior GxP IT Consultant

Boston, Massachusetts

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11d ago

Senior GxP IT Consultant The Senior GxP IT Consultant will be responsible for working cross-functionally and collaboratively with outside vendors on GxP specific systems support. 10+ years of relevant experience supporting GxP projects Location: MA or EST Contract Duration: 1 Year Contract Rates: $ 60/ph Key Responsibilities: Configure elluminate environments, modules, roles/permissions, and support compliant Release Management activities. Build and maintain ETL pipelines, metadata, mappings,

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Contract

Veeva Migration Consultant

Remote

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14d ago

We have a below position for Veeva Migration expert for remote work, please find the JD below and let me know your interest. Title: Veeva Migration Consultant Exp: 7+ to 10 years of experience in Veeva migration and implementation activities Duration: 6-12 Months Responsibilities: Migration Work stream Lead-Veeva RIMS Implementation Key Responsibilities Migration Strategy & PlanningDefine migration scope, timelines, resources, and success metrics.Develop detailed migration plans and risk mitiga

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Contract, Third Party

Depends on Experience

CSA Auditor, TraceLink

Remote

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25d 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

Global Maximo (OMX/MAS) Technical Lead and Administrator

Remote or Hybrid in Pittsburgh, Pennsylvania

•

Today

NTT DATA Services currently seeks a Global Maximo (OMX/MAS) Technical Lead & Administrator Project Overview Provide a comprehensive technical and security matrix as part of the new site implementation. This initiative includes conducting site-level settings workshops, delivering OMX orientation sessions for preventive maintenance and calibration for both GMP and non-GMP assets, and ensuring the new site fully adopts and aligns with existing OMX global policies and procedures. The selected consu

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Contract

BASED ON EXPERIENCE

Validation Engineer

Norwood, Massachusetts

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Today

Job Description: The purpose of the Validation Engineer (contract position) is to complete assignments in support of Quality and Engineering for equipment qualification, new product development, process validation and test method validation. The successful candidate will assume responsibility for drafting qualification protocols, qualification reports and engineering study reports, along with data analysis and an intermediate level of experience in the use of statistics. This position will also

Full-time

Senior Validation Engineer

Lexington, Massachusetts

•

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

•

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

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OQ jobs in Boston, MA, USA