fda Jobs in boston, ma

1 - 20 of 96 Jobs

LIMS LabvantageJob Title - LIMS Labvantage

Teamware SolutionsCompany Name - Teamware Solutions

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Boston, Massachusetts, USA

Contract

Job Role: LIMS Labvantage Location: Boston, MA (Day 1 Onsite) Duration: 6+ Months ROLE DESCRIPTION: Experience Required: 4 6 Years 3-5 years of experience providing IT support for LIMS systems in a pharmaceutical, biotech, or laboratory setting. Experience with LabVantage LIMS is a must. Strong understanding of laboratory processes, sample management, and analytical workflows. Experience with LIMS system configuration, master data updates, and user management. Familiarity with ITIL processes (in

Sr Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)Job Title - Sr Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

JobotCompany Name - Jobot

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Full-time

Sr Process Design Engineer / Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: We are a full-service engineering consulting firm providing services for a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, HVAC, plumbing

Sr Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)Job Title - Sr Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

JobotCompany Name - Jobot

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Full-time

Lead IT Validation ConsultantJob Title - Lead IT Validation Consultant

Amaze Systems IncCompany Name - Amaze Systems Inc

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New York, USA

Contract, Third Party

Lead IT Validation Consultant Remote Notes : Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. JD: We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used

Experienced Data ScientistJob Title - Experienced Data Scientist

Johnson & JohnsonCompany Name - Johnson & Johnson

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Danvers, Massachusetts, 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

LIMS and QC Applications ConsultantJob Title - LIMS and QC Applications Consultant

Expedite Technology SolutionsCompany Name - Expedite Technology Solutions

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Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an

Document Management Specialist | Remote | ContractJob Title - Document Management Specialist | Remote | Contract

Walker HealthforceCompany Name - Walker Healthforce

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Remote

Contract

Document Management Specialist | Remote | Contract Walker Healthforce is seeking a Document Management Specialist with +4 years of experience. This is a contract opportunity. CORE REQUIREMENTS:An A.A. in Business or English (or related) with four (4) years of experience OR Bachelor of Arts degree.Strong writing skills with good grammar.Attention to detail.Able to work on multiple documents in parallel.Able to create simple forms and templates.Must be able to use MS Office tools and interact with

Senior Validation EngineerJob Title - Senior Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Lexington, Massachusetts, USA

Full-time

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 (cG

EMBEDDED SOFTWARE TEST ENGINEERJob Title - EMBEDDED SOFTWARE TEST ENGINEER

Tekaccel, IncCompany Name - Tekaccel, Inc

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Cambridge, Massachusetts, USA

Full-time

Title: EMBEDDED SOFTWARE TEST ENGINEER Location: CAMBRIDGE, MA (100% ONSITE) Experience: 6+ Years Job Type: 6+ MONTHS CONTRACT TO FTE Job Description: MUST HAVE: EMBEDDED TESTING, RF DEVICES, AND PERFORMING RELATED TESTING, SPECTRUM ANALYZERS AND OSCILLOSCOPE, S FDA REGULATIONS (IEC 62304, 21 CFR PART 820), MEDICAL DEVICE BACKGROUND Required skills: Embedded testing experience Knowledge of IEC 62304, IEC 60601, and QMS 13485 Familiarity with networking terminology such as servers, switches, and

Validation Support EngineerJob Title - Validation Support Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Senior Mechanical Engineer - Med DeviceJob Title - Senior Mechanical Engineer - Med Device

Motion Recruitment Partners, LLCCompany Name - Motion Recruitment Partners, LLC

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Boston, Massachusetts, USA

Full-time

Our client, an established global leader in the diagnostics and medical device sector, is currently seeking a Senior Mechanical Engineer to join their growing R&D team. This role offers the opportunity to work on advanced diagnostic instruments and devices that directly impact patient care and clinical outcomes. Key Responsibilities: Lead the design and development of mechanical components and subsystems for complex medical devices, from concept through to production.Collaborate with cross-fun

Senior Validation EngineerJob Title - Senior Validation Engineer

Takeda pharmaceuticalCompany Name - 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

Clinical SAS programmerJob Title - Clinical SAS programmer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures, and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases. Perf

Software Verification EngineerJob Title - Software Verification Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Senior Mechanical EngineerJob Title - Senior Mechanical Engineer

Motion Recruitment Partners, LLCCompany Name - Motion Recruitment Partners, LLC

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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

Senior Design EngineerJob Title - Senior Design Engineer

SanofiCompany Name - Sanofi

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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

Associate Director, Human Factors & Usability EngineeringJob Title - Associate Director, Human Factors & Usability Engineering

SanofiCompany Name - Sanofi

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Cambridge, Massachusetts, USA

Full-time

Job DescriptionJob 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

Engineer III, ValidationJob Title - Engineer III, Validation

Thermo Fisher ScientificCompany Name - 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

Lead Mechanical EngineerJob Title - Lead Mechanical Engineer

Motion Recruitment Partners, LLCCompany Name - Motion Recruitment Partners, LLC

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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

Principal Validation EngineerJob Title - Principal Validation Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

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Danvers, Massachusetts, USA

Full-time