GMP Jobs in Massachusetts

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Lead Engineer, Quality Validation

Katalyst Healthcares and Lifesciences

•

Andover, Massachusetts, USA

Full-time

Job Description: The contract Lead Engineer, Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to laboratory instruments, temperature control units and LFH/BSC units for internal customers. The individual will support and facilitate the review and approval of qualification/validation documentation for all stages of the equipment life cycle qualification process. Responsibilities: Provide quality oversight of Bl
Posted 60+ days ago | Updated 5 hours ago

Automation Engineer

Katalyst Healthcares and Lifesciences

•

Framingham, Massachusetts, USA

Full-time

Roles & Responsibilities: Lead design, configuration, and commissioning of DeltaV and Client-X automation systems for GMP-critical manufacturing equipment and process controls. Support change controls, deviations, and CAPAs involving DeltaV and Client-X logic, batch strategies, and alarm configuration in collaboration with QA and Validation. Develop and modify control modules, phases, and equipment modules within DeltaV in alignment with S88 batch architecture standards. Provide hands-on trouble
Posted 52 days ago | Updated 5 hours ago

Winter/Spring 2026 Co-op/Intern - mRNA Data & Computational Science

Sanofi U.S.

•

Waltham, Massachusetts, USA

Full-time

Job Title: Winter, Spring 2026 Co-op-Intern - mRNA Data and Computational Science Location: Waltham, MA About the Job The Co-op position is located in the Data and Computational Science (DCS) department within the Sanofi mRNA Center of Excellence (mRNA CoE), supporting the CMC data science group. This role focuses on developing chemometric models using process analytical technologies (PAT) such as Raman and FTIR and integrating these with first principle and machine learning (ML) models for va
Posted 36 days ago | Updated 5 hours ago

Process Engineer

Katalyst Healthcares and Lifesciences

•

Remote or New York, USA

Full-time

Responsibilities: Senior Process Engineer responsible for tech transfers within the manufacturing team. Support GMP-related activities. Experience in tech transfer and project management. Strong technical skills, including report writing and problem-solving. Excellent communication skills, with the ability to clearly relay technical information. Cell Therapy (CAR-T) experience (preferred). Willingness to travel (approximately 25%). t least 5 years of relevant experience.
Posted 60+ days ago | Updated 5 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

•

Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and
Posted 60+ days ago | Updated 5 hours ago

Senior Director IT Quality Assurance & Compliance

Regeneron Pharmaceutical

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Remote or Sleepy Hollow, New York, USA

Full-time

As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, coaching, and technical support to the IT QA & Compliance Management Team. This role is an on-site position 4 days/week at our Sleepy Hollow, NY or Warren, NJ office. There will be occasional travel to other sites in the Rensselaer, NY area. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option. A typical
Posted 41 days ago | Updated 5 hours ago

Sr. Spclst , Technical Support

Merck & Company Inc

•

Remote or Rahway, New Jersey, USA

Full-time

Job Description Business Technology Partner Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We partner internationally to deliver the services and solutions that help development scientists to be more productive and enable innovation. The BTP ensures translation of business strategy to IT strategy, relevant communication to business and IT functions, and develop strategic digital roadmaps, and lead delivery of ca
Posted 5 days ago | Updated 5 hours ago

Commercial Operations Sales Analytics (Remote)

Pace® Life Sciences

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Remote or Oakdale, Minnesota, USA

Full-time

About Us Pace Life Sciences Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations. Job Description Commercial Operations - Sales Analytics We are looking for a self-starter, with strong dat
Posted 12 days ago | Updated 1 hour ago

Lab IT Helpdesk | Toronto, Canada | Onsite

Stellent IT LLC

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Boston, Massachusetts, USA

Third Party

Title: Lab IT Helpdesk Location: Toronto, Canada | Onsite Duration: 6-12+ Months Must: Helpdesk setting up conferences and meeting rooms - JIRA AWS / AZURE basic cloud technology experience. Local to Toronto from day 3 years helpdesk experience in biotech, 10+ years of general helpdesk experience in general. Most current project needs to be in Biotech. Lab systems experience preferred BENCH LIMS. General LIMS as secondary if no bench LIMS. Description of Position: Reporting into the Director o
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Posted 30 days ago | Updated 17 hours ago

Principal Engineer - Thermal Engineering

Amgen Inc

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Remote or Thousand Oaks, California, USA

Full-time

Career Category Engineering Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients ea
Posted 60+ days ago | Updated 5 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

•

Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 19 days ago | Updated 5 hours ago

Senior Staff Firmware Engineer (Hybrid)

Becton Dickinson & Company

•

Remote or Milpitas, California, USA

Full-time

Job Description Summary Seeking an experienced Senior Staff Firmware Engineer to lead the development and evolution of high-quality instrument control firmware for BD's flow cytometers. You will provide technical leadership and architectural guidance to ensure robust and reliable firmware solutions. As a key member of the firmware development team, you will architect, develop, debug, and document firmware that meets product requirements with high reliability and robustness. You will provide sig
Posted 60+ days ago | Updated 5 hours ago

Staff Engineer II, Firmware (Hybrid)

Becton Dickinson & Company

•

Remote or Milpitas, California, USA

Full-time

Job Description Summary Seeking an experienced staff level Firmware Development Engineer to play a leading role in developing high quality instrument control firmware for BD's line of flow cytometers. As a leading member of the firmware development team, you will be responsible for architecting, developing, debugging, and documenting robust and reliable firmware to satisfy the product requirements. Must be detail-oriented, process-focused, and results-driven. Are you ready to make a difference
Posted 60+ days ago | Updated 5 hours ago

Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.

•

Remote or Santa Monica, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 55 days ago | Updated 5 hours ago

Seeq Implementation & Support Consultant-W2 ONLY

VetForce Solutions

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Remote

Contract

ResponsibilitiesDuring Implementation Phase: Lead release management and environment coordination for Seeq (SaaS) Establish and enforce SDLC best practices, including code workflows and version control Support integration across ~12 data sources (e.g., OSI PI, Data Lakes, Unicorn, Nova) Drive CSV/CSA efforts, including documentation, risk assessment, and audit readiness Contribute to SOP authoring, compliance strategy, and data governance Post-Go-Live Operations: Develop advanced analytics and d
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Posted 2 days ago

Software Engineer with Syncade @ Boston, MA

Hermitage Info Tech, LLC.

•

Boston, Massachusetts, USA

Contract

Day 1 onsite Role: Software Engineer with Syncade Boston, MA Qualifications Thorough understanding of ISA S88 and S95 models Knowledge of CSV, GAMP and 21 CFR Part 11 regulations Bachelor's degree in Chemical/Electrical/Computer Engineering, or equivalent combination of education and technical experience Minimum four (4) years of design/development/deployment experience in Emerson Syncade MES DeltaV Batch programming or Syncade Recipe development experience Work experience in a Pharmaceutical/
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Posted 20 hours ago

Need Senior Manufacturing Quality Engineer

Montek System

•

Ayer, Massachusetts, USA

Contract, Third Party

Onsite, Devens location Work Schedule: Mon - Fri, First shift (8:30AM - 5PM) Top Skills/Must Haves: Quality Control Equipment experience preferredTechnical WriterInvestigations/Deviation experience preferred Job Description/ Responsibilities: Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review andapproval of Investigations and Corrective Actions. Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectati
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Posted 1 day ago

LIMS/ELN Scientific Application Specialist Digital & AI, laboratory informatics, Experience in data analysis and management

Xoriant Corporation

•

Boston, Massachusetts, USA

Contract

Scientific Application Specialist Digital & AI, laboratory informatics, Experience in data analysis and management The target pay rate ranges between $60 - $62 Per Hour on W2 TRUE JOB TITLE: Scientific Application Specialist Digital & AI LOCATION: 300 North Beacon, Suite 501 Watertown, MA SCHEDULE: Onsite 5 days, M-F DURATION: 6 months TOP SKILLS per MANAGER: 1. Experience in laboratory informatics 2. Experience in data analysis and management 3. Technical knowledge of digital solutionsWe are l
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Posted 28 days ago | Updated 17 hours ago

Engineering - Bio Process Associate - 1st Shift , Devens MA

Futran Solutions

•

Massachusetts, USA

Contract

Job Description: Bio Process Associate 1st Shift--hours are 7AM - 3PM Monday - Friday. Onsite, Devens--Local candidates Only **Note there are 3 openings on this req** Description: The Bioprocess Associate uses current Good Manufacturing Practices (cGMPs) in the execution of commercial manufacturing processes for the manufacture of therapeutic proteins used in medicines that are revolutionizing the treatment of serious disease. Job Responsibilities: Operate production equipment within an assign
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Posted 60+ days ago | Updated 14 days ago

SAP EWM Consultant

Genius Business Solutions

•

Remote

Contract, Third Party

Are you a passionate IT trailblazer a growth focused, problem solver who takes full ownership of your work, wants to collaborate & co-create with fellow IT experts, innovate, learn new skills, create new solutions & drive your career to the pinnacle of your potential? If so, you will love working with our Sales Team we are constantly innovating to create breakthrough solutions for our client s growth through a vibrant, fun team culture. Read on below to learn more Featured in CNBC, Digital Journ
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Posted 60+ days ago | Updated 6 days ago