fda Jobs in massachusetts

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Validation Engineer

Katalyst Healthcares and Lifesciences

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Fall River, Massachusetts, USA

Full-time

Job Description: The Validation Engineer is responsible for developing DQ/IQ/OQ/PQ protocols and coordinating and performing equipment qualifications, ensuring that automated process equipment that mass produce medical device consumables and other products, are designed, developed or changed in compliance with specifications, requirements, safety and Company and regulatory guidelines. The Validation Engineer will work closely with Senior validation staff, maintenance, operations, and R&D teams t
Posted 3 days ago | Updated 9 hours ago

Senior 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 5 days ago | Updated 9 hours ago

Sr. Ultrasound Acoustic Engineer

Johnson & Johnson

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Remote or Santa Clara, California, 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 5 days ago | Updated 9 hours ago

Senior Appian Developer

Next Gen Software Solutions LLC

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Remote

Contract

Job Title: Senior Appian Developer Location: Silver Spring, MD (Remote Position) Type: Contract (W2 through Next Gen Software Solutions LLC only No C2C) Duration: 12+ Months (Long-term) Pay Rate: $53 - $58/hour (W2) Note: Candidates must have an FDA Public Trust badge to qualify. Job Description Are you an experienced Appian Developer looking for a long-term opportunity to work on cutting-edge projects in a remote environment? Join Next Gen Software Solutions LLC as a Senior Appian Developer
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Posted 18 days ago | Updated 18 days ago

LabVantage LIMS Architect

I.T. Solutions

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Remote

Contract

Role: Sr. LabVantage LIMS Architect Location: Remote Type: Contract Length: 3 months to start + Likely Extensions We are seeking an experienced LabVantage LIMS Architect to lead the design, configuration, and implementation of LabVantage Laboratory Information Management Systems (LIMS). The ideal candidate will possess deep technical expertise in LabVantage, a strong understanding of laboratory workflows, and a proven ability to align LIMS capabilities with business and regulatory requirements.
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Posted 2 days ago

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

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Marlborough, Massachusetts, USA

Full-time

Responsibilities: Derive test requirements from the design specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign. Establish acceptance criteria, sampling, assess through modeling or qualitative/quantitative testing, evaluate the performance according to URS, SRS (design inputs and outputs). Write test protocol, setup design of experiments, execute tests, analyse results and document reports for design verificati
Posted 3 days ago | Updated 9 hours ago

Sycamore SCE Administrator (Statistical Computing Environment)

Virtualan Software

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Boston, Massachusetts, USA

Third Party, Contract

Job Title: Sycamore SCE Administrator (Statistical Computing Environment) Location: Hybrid at Boston, MA Job Type: C2C / Full time Overview: We are seeking an experienced Sycamore SCE Administrator to manage and maintain our Statistical Computing Environment (SCE) used for clinical and statistical analysis. The ideal candidate will have deep hands-on experience with the Sycamore platform and a strong background in statistical computing within regulated environments such as pharmaceuticals or lif
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Posted 20 days ago

Engineering Co-op

Fresenius Medical Care

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Lawrence, Massachusetts, USA

Full-time

INVENT. IMPROVE. INSPIRE. NxStage Medical, a Fresenius company is not your typical medical products company. We are a close-knit team of talented professionals driven by a shared commitment: to lead a movement to dramatically improve renal care with innovative yet simple therapeutic solutions that benefit patients, caregivers, and society. We pursue this goal through a passionate commitment to Innovate, Educate, and Advocate for the breakthroughs that are redefining renal care. Additionally, NxS
Posted 12 days ago | Updated 9 hours ago

SAP OPAL Label Consultant

Stefanini

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Rome, Lazio, Italy

Contract

Stefanini Group is looking for a SAP OPAL Label Consultant for a globally recognized company! For interested applicants, click the apply button or you may reach out Micah Andres at / for faster processing. Thank you! Job Title: SAP OPal Label Consultant Job Description: We are seeking a skilled SAP OPal (One Platform for All Labels) Label Consultant to join our team. The ideal candidate will be responsible for designing, configuring, and implementing labeling solutions within the SAP environment
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Posted 27 days ago | Updated moments ago

Infor M3 Implementation Consultant

SigmaWay

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Remote

Contract

Apply by Email/Direct Application at Role: Infor M3 Implementation Consultant Duration: 6 to 12 months REMOTE: Yes (some travel to San Diego might be required) Client Location: San Diego, CA Job Description Must have experience in the food industry Hands-on Infor M3 implementation experience, including migrations from Legacy LX and/or SAP. Experience in food manufacturing or food distribution, with an understanding of data, shelf life, and expiration management actively seeking a hands-on Infor
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Posted 6 days ago | Updated 5 days ago

Senior Reg Ops Specialist SME

LMI Government Consulting (Logistics Management In

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Remote

Contract

Overview LMI is seeking a Senior Reg Ops Specialist SME to support the Biomedical Advanced Research and Development Authority (BARDA). This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates w
Posted 60+ days ago | Updated 6 hours ago

AI Engineer

Thermo Fisher Scientific

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Remote or Chicago, Illinois, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join us as an AI Engineer to implement innovative AI and ML methods for our GxP Quality Management System. Key Responsibilities: Build AI Solutions: Develop predictive models, anomaly detection systems, and LLMs to optimize QMS performance.Improve GenAI and LLMs: Apply Generative AI techniques and LLMs to automate and improve tasks like quality events analysis, document reviews, and complaint management.Work wit
Posted 45 days ago | Updated 9 hours ago

Enterprise Architect (Remote)

Beacon Systems, Inc

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Remote or Richmond, Virginia, USA

Contract

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial State, and Local Agencies. We are a subsidiary of Radiant Digital Services. We have a vast portfolio of clients across the country. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position: Enterprise ArchitectLocatio
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Posted 4 days ago | Updated 1 day ago

Supervisor, Purchasing

KARL STORZ Endoscopy - America

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Charlton, Massachusetts, USA

Full-time

Job Title: Supervisor, Purchasing Location: Charlton, MA or Goleta (Santa Barbara), CA Department: Supply Chain Key Responsibilities: Lead, train, and support the purchasing team in day-to-day operations, ensuring compliance with standards and work instructions. Analyze proposals, financial reports, and data to formulate sourcing strategies aligned with company goals. Negotiate contracts and manage purchase orders with suppliers, ensuring cost-effectiveness and timely delivery. Track and report
Posted 45 days ago | Updated 14 hours ago

Operations Manager

Advantage Technical

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Ayer, Massachusetts, USA

Full-time

We're looking for a dynamic Operations Manager to lead our client's production team in delivering top-tier results in safety, quality, cost efficiency, and productivity. If you're passionate about people development, operational excellence, and driving performance in a fast-paced manufacturing environment - this is your opportunity to make an impact. Salary: Up to $95,000/yr. Schedule: Sunday - Thursday, 11pm - 7am 20% bonus Key Responsibilities: Lead production operations to meet performance
Posted 4 days ago | Updated 6 hours ago

Senior Regulatory Affairs SME

LMI Government Consulting (Logistics Management In

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Remote

Contract

Overview LMI is seeking a Senior Regulatory Affairs SME to support the Biomedical Advanced Research and Development Authority (BARDA). This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates w
Posted 60+ days ago | Updated 6 hours ago

Sr. Systems Engineer

Fresenius Medical Care

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Lawrence, Massachusetts, USA

Full-time

PURPOSE AND SCOPE: The Sr. Engineer possesses specific product lines knowledge to be a resource and key technical expert to support related projects. The Sr. Engineer is largely unsupervised and self-motivated to lead projects. Shall be capable of being given high level tasks and working independently to organize work, from required Cross Functional Teams (CFT) and to produce the final product or outcome assigned. The Sr. Engineer is expected to be trusted to provide production support to ensure
Posted 25 days ago | Updated 9 hours ago

Senior Automation Engineer

Merck KgaA

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Bedford, Massachusetts, USA

Full-time

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
Posted 38 days ago | Updated 9 hours ago

Engineer Principal

Aditi Consulting

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Remote or Thousand Oaks, California, USA

Contract

Payrate: $85.00 - $87.00/hr. Summary: The ideal candidate for the Principal Automation Engineer (Delta V) role will have extensive expertise in Delta V batch control systems, with a minimum of 4-5 years of direct, hands-on Delta V experience specifically in pharmaceutical manufacturing environments. They should demonstrate proficiency in coding, troubleshooting, and addressing complex alarms or system issues in Delta V. A strategic mindset, excellent troubleshooting skills, and strong interperso
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Posted 4 days ago | Updated moments ago

Data Science Engineer

Takeda pharmaceutical

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Lexington, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by
Posted 27 days ago | Updated 9 hours ago