fda Jobs in massachusetts

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Software Verification Engineer

Katalyst Healthcares and Lifesciences

•

Newton, Massachusetts, USA

Full-time

Job Description: We are seeking a meticulous and detail-oriented Medical Device Software Verification Tester to join our team. The successful candidate will be responsible for verifying software used in our medical devices and ensuring compliance with regulatory standards and internal quality requirements. This role involves designing, implementing, and executing test plans and procedures to identify and document software defects. Responsibilities: Test Planning and Design. Develop comprehensi
Posted 58 days ago | Updated 10 hours ago

DTS Lead - Intelligent Clinical Supply Management

Quantum Integrators Group LLC

•

Remote or King of Prussia, Pennsylvania, USA

Contract, Third Party

Role Name: DTS Lead - Intelligent Clinical Supply Management (ICSM) Location: King of Prussia, PA. REMOTE 6+ Months contract Job Description The DTS Lead ICSM is responsible for leading the design, implementation, and optimization of SAP's Intelligent Clinical Supply Management (ICSM) solution. This role supports clinical trial operations by ensuring efficient planning, forecasting, packaging, labeling, and distribution of clinical trial materials across global sites, while maintaining regulato
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Posted 5 days ago | Updated 4 hours ago

Software Engineer - Embedded C, C#, C++ | Marlborough, MA

Michael Page International

•

Marlborough, Massachusetts, USA

Full-time

Join a revolutionary medical device manufacturing organizationWork with a team making a difference to patients all over the world About Our Client The company is a medical device organization that design and develop cutting-edge software for complex medical devices. They have an FDA approved device that is live in the US, Europe & Asia and they're looking to further grow their R&D team with this hire, and plan to continue their growth for the remainder of 2025 and into 2026! Job Description
Posted 6 days ago | Updated 8 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 49 days ago | Updated 10 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

•

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 10 hours ago

Senior Mechanical Engineer

Motion Recruitment Partners, LLC

•

Boston, Massachusetts, USA

Full-time

Our client, a leading medical device company, is seeking a Senior Mechanical Engineer to join their R&D team. This role involves contributing to the design, development, and support of diagnostic systems and electromechanical components in a regulated environment. The ideal candidate will have a strong background in mechanical design, experience with complex assemblies, and a track record of bringing products from concept through development and into manufacturing. This is a hands-on engineering
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Posted 48 days ago | Updated 7 hours ago

Senior Design Engineer

Sanofi

•

Cambridge, Massachusetts, USA

Full-time

Job Title: Senior Design Engineer Location: Cambridge, MA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. You serve as a crucial member of the Global Device Platform Engineering Team, taking responsibility for ensuring robus
Posted 12 hours ago | Updated 1 hour ago

Senior Quality Assurance Systems Specialist

Nitto Denko Corp.

•

Milford, Massachusetts, USA

Full-time

Job DescriptionAbout this opportunity : The Senior Quality Systems Specialist, QA will be responsible for performing QA review and approval of Change Controls, Deviations, CAPAs, Batch Records, and associated GMP documentation to ensure compliance with applicable regulatory standards (FDA, EMA, ICH). This role serves as a Subject Matter Expert (SME) for Change Management processes across multiple sites (Milford, Irvine, and Cincinnati), and requires hands-on knowledge of Veeva and TrackWise sys
Posted 1 day ago | Updated 8 hours ago

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

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
Posted 8 days ago | Updated 10 hours ago

IT Enterprise Architect with Life Science Experience

K Source Inc

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Remote

Contract, Third Party

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: IT Enterprise Architect with Life Science Experience Location: Boston, MA (Remote) Duration: 12+ months Job Description: The IT Enterprise Architect is a key role within Gates MRI IT, combing a blend of deep technical and architectural expertise with industry foresight, and strategic thinking. This position is essential for crafting a cohesive IT architecture that sup
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Posted 3 days ago

Site Compliance Quality Head

Software Guidance & Assistance

•

Billerica, Massachusetts, USA

Full-time

Software Guidance & Assistance, Inc., (SGA), is searching for a Site Compliance Quality Head for a FULL-TIME assignment with one of our premier Pharmaceutical Services clients in Billerica, MA. Responsibilities: Implement and manage the records in electronic Quality Systems, such as QMS, EDMS, and LMS, etc. providing procedures and training for employees to effectively use the electronic Quality Systems Supervise the QA Documentation department in the creation, issuance, maintenance, archivi
Posted 18 days ago | Updated 9 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 28 days ago | Updated 10 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 27 days ago | Updated 10 hours ago

Lead Mechanical Engineer

Motion Recruitment Partners, LLC

•

Boston, Massachusetts, USA

Full-time

Our client, an innovative diagnostic medical device company, is seeking a Lead Mechanical Engineer to join their team. This individual will play a critical role in leading the design, development, and refinement of mechanical systems for next-generation diagnostic products. The company is committed to transforming point-of-care diagnostics and is looking for someone who thrives in a collaborative, fast-paced environment. This is an excellent opportunity for an experienced mechanical engineer who
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Posted 44 days ago | Updated 7 hours ago

Integration Specialist - Informatica/AWS

Sanofi

•

Cambridge, Massachusetts, USA

Full-time

Job Title: Integration Specialist - Informatica / AWS Location: Cambridge, MA OR Morristown, NJ About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. At Sanofi, we're committed to providing the next-gen healthcare that patients and customers need. It's about harnessing data insights and leveraging AI responsib
Posted 12 hours ago | Updated 1 hour ago

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 10 hours ago

Senior Appian Developer

General Dynamics

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Remote

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Engineering Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: None Experience: 5 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fill multiple-level Appian Developer roles on
Posted 49 days ago | Updated 10 hours ago

Associate Director, Human Factors & Usability Engineering

Sanofi U.S.

•

Cambridge, Massachusetts, USA

Full-time

Job title: Associate Director, Human Factors & Usability Engineering Location: Cambridge, MA, Morristown, NJ About the job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. At Sanofi, we chase the miracles of science to improve people's liv
Posted 15 days ago | Updated 10 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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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 16 days ago | Updated 10 hours ago

Senior Clinical Outcomes Assessment (COA) Lead

Sanofi

•

Cambridge, Massachusetts, USA

Full-time

Job Title: Senior Clinical Outcomes Assessment (COA) Lead Location: Cambridge, MA, Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The remit of the Clinical Outcome Assessment (COA) team at Sanofi is to incorporate the patients' perspective (and other subjective perspectives) into clinica
Posted 12 hours ago | Updated 1 hour ago