FDA jobs in Raritan, NJ

Raritan, New Jersey

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17d ago

Job Summary for CSV Engineer - Industry Experience: 3-7+ years of relevant experience in pharmaceutical, biotechnology, or medical device industries. - System Development Lifecycle: Proficient in Computer System Validation (CSV), especially in FDA and/or globally regulated environments. - Regulatory Standards: Strong understanding of GxP standards, risk-based validation, FDA guidances, and industry standards (e.g., GAMP). - Validation Documentation: Skilled in writing and executing validat

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Third Party, Contract

$50 - $56

GRC Analyst

Remote

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3d ago

This is a 3 Month Contract to Hire Opportunity. This position is 100% Remote. This is an outstanding opportunity for a Sr. GRC Analyst to participate in large global GRC initiatives that literally save lives. We are a leading global biotech company committed to improving human health through scientific innovation. With a 50+ year legacy of excellence, our publicly traded organization employs over 7,000 global team members, holds 750+ product patents, and generates $6.6 billion in revenue with $1

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Contract

$60 - $70

CSV Lead

Raritan, New Jersey

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Yesterday

Job Title- CSV Lead Job Location- Raritan, NJ (onsite) Job Description- Candidates need to have hands-on experience in validating and implementing infrastructure systems associated with Infrastructure related applications. Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years experience with System Development Lifecyle 3+ years experience in Computer System Validation (Based on the role selected) Experience in FDA and/or Global regulated environm

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Contract, Third Party

Depends on Experience

Chemist II - Analytical Chemistry (HPLC, cGMP)

South Plainfield, New Jersey

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Today

Chemist II - FDA cGMP Analytical Lab | 100% Onsite | Growing Pharmaceutical Testing Laboratory This Jobot Job is hosted by: Ron Calhoun Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $70,000 - $80,000 per year A bit about us: Founded over 20 years ago and based in South Plainfield, NJ, we are an FDA-registered, cGMP-compliant analytical testing laboratory specializing in OTC drugs, pharmaceuticals, cosmetics, dietary supplements, and botan

Full-time

USD 70,000.00 - 80,000.00 per year

Validation Lead

Hybrid in Raritan, New Jersey

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22d ago

Role - Validation Lead Location - Raritan, NJ(Hybrid) Key Responsibilities Candidates need to have hands-on experience in validating GxP GEN AI based solutions and LSMV Safety and PharmacovigilancesystemAbility to manage multiple dispositions for multiple J&J Managers with limited supervision.Ability to manage end-end from Inventory, assessments, remediations to final dispositions; 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources. Specifically in

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Contract

Depends on Experience

Sr. CSV/CSA/Validation Engineer

Raritan, New Jersey

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14d ago

Roles & Responsibilities: Need someone strong with GXP applications, saas/paas, infrastructure, quality, cloud concepts, cloud applications, etc. In addition to validation and regulation experience, the resource should have the following experience: Must be able to Independently support Business Separation activities for Large global & regional GxP Computerized systems. With minimal supervison. Strong CSV Expertise, especially within Acquisition/Divestiture/Separation. bility to manage end-end f

Full-time

Veeva QMS Business Analyst

Princeton, New Jersey

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Today

Job Title: Veeva QMS Business Analyst Location:Princeton, New Jersey - Hybrid Job Description: We are seeking an experienced Veeva QMS Business Analyst with strong expertise in business requirements gathering, BRD/FRS documentation, gap analysis, and workflow configuration within regulated Life Sciences environments. The candidate will work closely with business stakeholders, Quality teams, and technical teams to analyze business processes, manage system requirements, and support Veeva Qu

Full-time, Third Party

Depends on Experience

Senior Material Excellence Engineer, Site MSAT

Raritan, New Jersey

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Today

Job Title: Senior Material Excellence Engineer, Site MSAT Location: Raritan, NJ 12+ Months Contract Position Summary: The Senior Material Excellence Engineer, Site MSAT will lead global implementation initiatives for the dual sourcing of Lentivirus (LV) materials under Project S.U.R.G.E (Single Use Resiliency & Growth Evolution). This role drives operational reliability, innovation, and sustainability across internal and external global manufacturing facilities. Operating within a cross-funct

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Full-time, Contract, Third Party

JD Edwards E1 Developer

Rockaway, New Jersey

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Today

Job Title: JD Edwards E1 Developer Location: Rockaway, NJ Duration: Full-Time (FTE, Direct Hire) Schedule: Hybrid Role Job Description: IMPACT: The JDE E1 Developer will play a key role in enhancing and supporting critical business operations by developing, customizing, and optimizing JD Edwards EnterpriseOne solutions. ROLE: Reporting to the Director - Enterprise Systems, the Developer will improve system functionality, resolve technical issues, ensure quality and reliability, and help deli

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

Electrical Engineer

Florham Park, New Jersey

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Today

The Electrical Engineer supports the transfer of new electro-mechanical product designs from R&D to Manufacturing, and also supports day-to-day manufacturing operations. The role is focused on continuous process improvement and cost out to enable the business to operate more efficiently while delivering to the customer. Key Areas of Responsibility: Work with Repair Technicians to ensure troubleshooting & repair is effective & efficient.Recommend design changes to improve product quality, perfor

Full-time

Human Factors and Usability Engineering Director

Morristown, New Jersey

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Today

Job Title: Human Factors & Usability Engineering Director Location: Morristown, NJ or Cambridge, MA About the Job Drug Product Development & Delivery is a global business unit in Manufacturing & Supply (M&S) which develops and maintains Sanofi's parenteral injection systems including Insulin Pens, Autoinjectors, Large Volume Devices, infusion systems, and Pre-Filled Syringes. The unit is a project-centric organization executing early stage, development. and Lifecycle Management (LCM) projects o

Full-time

USD 178,500.00 - 257,833.33 per year

Trade Compliance Analyst

Remote or New York, New York

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Today

Title: - Trade Compliance Analyst Location: New York, NY, 10001 Duration: 12 months (possible for extensions) Fully Remote Position Job Description: Trade Compliance Analyst Position Summary: The Trade Compliance Analyst is responsible for supporting U.S. import compliance activities and ensuring adherence to U.S. Customs regulations and Partner Government Agency (PGA) requirements. This role partners with customs brokers, government agencies, logistics providers, and internal stakeholders to

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Contract, Third Party

$Market

BRM/ Engagement Manager

Hybrid in Edison, New Jersey

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3d ago

Exp. Required: 10+ Years The Engagement Manager will own and strengthen strategic customer relationships across business and IT functions within the United States. The role is responsible for driving account growth, executive stakeholder engagement, business value realization, and digital transformation initiatives while positioning as a trusted strategic partner. Must-Have Qualifications Prior experience managing large strategic MedTech accounts with significant business responsibility and gr

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Full-time

160,000 - 190,000

Sr. Techno-Functional Consultant

Parsippany-Troy Hills, New Jersey

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8d ago

Amtex SystemsInc is an information technology and talent solutions company offering talent and BI consulting to the companies in US for over 25 years. Our solutions are designed to fill resource gaps, by providing the right candidates who deliver value to the organization. Our propensity to nurture and build strong relationships with our clients helps us better understand their business demands and gives us the ability to provide services that are on time and rise above the rest. Sr. Techno-Func

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Third Party, Contract

Depends on Experience

Senior Automation Engineer (GMP)

Pennington, New Jersey

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Today

Senior Automation Engineer (GMP) Location: Pennington, NJ (Fully Onsite) Employment Type: Full-Time, Permanent Salary Range: $120,000 $150,000 per year Industry: Biotechnology / Biopharmaceutical Manufacturing About the Opportunity We are seeking a Senior Automation Engineer to support the administration, maintenance, validation, and continuous improvement of automation systems within a regulated biopharmaceutical manufacturing environment. This role focuses on SCADA systems, industrial au

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Full-time

$120000-150000

Senior Lab Support Engineer

New Brunswick, New Jersey

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting Job Description Job Title: Instrument Qualification Specialist This is a fully onsite role based at our customer's site in New Brunswick, NJ. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship.

Full-time

USD 95,000.00 - 100,000.00 per year

Process Validation Engineer

Newark, New Jersey

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14d ago

Job Description: We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification activities for pre-filled syringe (PFS) manufacturing lines. The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure successful project delivery and regulatory compliance. Respon

Full-time

Environmental Health and Safety - Senior Manager

Piscataway, New Jersey

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Today

Description: Job Summary The Senior Environmental Health & Safety (EHS) Manager is a full-time, exempt position at Kashiv BioSciences, LLC, responsible for leading and overseeing comprehensive EHS programs across two sites in New Jersey and Chicago. This role drives the development, implementation, and continuous improvement of initiatives that promote a safe and compliant work environment within a fast-paced biopharmaceutical production setting. The ideal candidate will ensure adherence to al

Full-time

USD 160,000.00 - 180,000.00 per year

Senior Field Service Engineer

New Brunswick, New Jersey

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Today

Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Full-time

USD 100,000.00 - 130,000.00 per year

Data Engineering Manager

Remote or New York, New York

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Today

About Imagen Imagen Technologies is building the AI-enabled teleradiology practice of the future. We operate the first vertically integrated medical practice and AI development platform focused on reducing diagnostic error and giving radiologists superpowers through industry-leading AI solutions developed in-house. With over $200 million in funding from investors such as Google Ventures and some of the largest clinical networks in the country, we are rapidly expanding this platform across the U

Full-time

USD 200,000.00 - 250,000.00 per year

FDA jobs in Raritan, NJ, USA