21 CFR Part 11 Jobs in Jersey City, NJ

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LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

•

Remote

Contract, Third Party

Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integrations, and data flows Working with ELNs (Electronic Lab Notebooks) and lab automation Basic understanding of data security, validation, and integrity in lab system Skills: Business Analysis Skills: Requirements gathering and documentation Proce
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Posted 6 days ago | Updated 4 hours ago

SAP SSAM (Service and Asset Management) Consultant :: Hybrid :: C2C/ W2

Trebecon LLC

•

Jersey City, New Jersey, USA

Contract

Role : SAP SSAM (Service and Asset Management) Consultant Location : Hybrid - New Jersey Key Responsibilities:Lead and support the design, configuration, and implementation of SAP SSAM solutions in alignment with industry best practices.Engage in full lifecycle SAP SSAM projects including requirements gathering, blueprinting, functional specs, testing, training, and go-live.Collaborate with business teams in the life sciences/pharma/medical device sector to understand operational and compliance
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Posted 8 hours ago

SAP SSAM (Service and Asset Management) Consultant | Hybrid | C2C

Trebecon LLC

•

Jersey City, New Jersey, USA

Contract

Role: SAP SSAM Consultant Location: NJ- Hybrid Key Responsibilities:Lead and support the design, configuration, and implementation of SAP SSAM solutions in alignment with industry best practices.Engage in full lifecycle SAP SSAM projects including requirements gathering, blueprinting, functional specs, testing, training, and go-live.Collaborate with business teams in the life sciences/pharma/medical device sector to understand operational and compliance requirements.Configure integration betwe
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Posted 8 hours ago

SAP SSAM (Service and Asset Management) Consultant :: C2C

Trebecon LLC

•

Jersey City, New Jersey, USA

Contract, Third Party

Role: SAP SSAM (Service and Asset Management) Consultant Location: Hybrid, New Jersey Experience Level: Senior (10+ years) Job Description: We are seeking an experienced and certified SAP SSAM (Service and Asset Management) Consultant to lead and support the implementation, optimization, and support of SAP SSAM solutions within a regulated industry environment. The ideal candidate will have deep functional and technical knowledge of SAP EAM (Enterprise Asset Management) and SAP SSAM, along wi
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Posted 8 hours ago

SAP SSAM (Service and Asset Management) Consultant :: Hybrid

Trebecon LLC

•

Jersey City, New Jersey, USA

Contract

Role: SAP SSAM (Service and Asset Management) Consultant Location: Hybrid, New Jersey Duration: 6 months to 1 year Industry: Life Sciences / Pharmaceuticals / Medical Devices Experience Level: Senior (10+ years) Job Description: We are seeking an experienced and certified SAP SSAM (Service and Asset Management) Consultant to lead and support the implementation, optimization, and support of SAP SSAM solutions within a regulated industry environment. The ideal candidate will have deep functi
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Posted 8 hours ago

NOW HIRING: SAP GTS to E4H Migration Consultant

Global IT Family

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Rahway, New Jersey, USA

Contract

NOW HIRING: SAP GTS to E4H Migration Consultant Location: Rahway, NJ (Onsite) Rate: $110/hr W2 (All-Inclusive) Experience: 10+ Years Domain: Pharma & Life Sciences Background Mandatory Visa: -EAD, GC-EAD ONLY We are looking for a Senior SAP GTS Consultant with hands-on migration experience from SAP GTS to E4H (Enterprise for High-tech) to support a strategic transformation initiative in Rahway, NJ. This role is ideal for a functional expert who has worked in regulated pharma/life sciences
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Posted 8 hours ago

NOW HIRING: SAP SAM (Service and Asset Management) Lead Consultant

Global IT Family

•

Piscataway, New Jersey, USA

Contract

NOW HIRING: SAP SAM (Service and Asset Management) Lead Consultant Location: Piscataway, NJ Hybrid Rate: $110/hr W2 (All-Inclusive) Experience: 10+ Years Domain: Pharma & Life Sciences Background Mandatory Visa: -EAD, GC-EAD ONLY We are actively seeking an experienced SAP SAM Lead Consultant to support a strategic program in Piscataway, NJ. This is a hybrid role for professionals with deep expertise in SAP Service and Asset Management and a strong background in Pharmaceutical or Life Scien
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Posted 8 hours ago

NOW HIRING: SAP IAM/APM Solutions Architect

Global IT Family

•

Piscataway, New Jersey, USA

Contract

NOW HIRING: SAP IAM/APM Solutions Architect Location: Piscataway, New Jersey (Hybrid) Rate: $110/hr W2 (All-Inclusive) Experience: 10+ Years Domain: Pharma & Life Sciences Background Mandatory We are seeking an SAP IAM/APM Solutions Architect with a strong background in Pharma and Life Sciences to join a leading project in New Jersey. This is a high-visibility, hands-on role ideal for professionals with deep expertise in SAP Identity and Access Management (IAM) and Asset Performance Managem
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Posted 8 hours ago

MS Dynamics Platform Product Lead / Integration Tech Lead

ARMO Consultants

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Parsippany-Troy Hills, New Jersey, USA

Full-time

About the Role:We are seeking a senior-level Tech Lead with deep expertise in Microsoft Dynamics 365 and the Power Platform to lead the design, development, and integration of enterprise-grade solutions across our pharmaceutical business units. This role combines product ownership, technical leadership, and hands-on development, with a strong focus on automation, compliance, and scalability.Key Responsibilities:Lead architecture, development, and integration of Microsoft Dynamics 365 (CE, F&O) a
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Posted 20 days ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Summit, New Jersey, USA

Full-time

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Supports equipment qualification and systems validation activities. Configures and documents the configuration of computerized systems. Develops
Posted 19 days ago | Updated 2 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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New Brunswick, New Jersey, USA

Full-time

Job description: We're seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. You'll partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions. Responsibilities: Lead end
Posted 60+ days ago | Updated 2 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

•

New Brunswick, New Jersey, USA

Full-time

Responsibilities: Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in establishing standard quality and validation pract
Posted 60+ days ago | Updated 2 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Summit, New Jersey, USA

Full-time

Position Overview: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions and uses ba
Posted 60+ days ago | Updated 2 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Warren, New Jersey, USA

Full-time

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Supports calibration, equipment qualification and validation activities. Configures and documents the configuration of computerized systems. Dev
Posted 52 days ago | Updated 2 hours ago

Software Quality Engineering Lead

Johnson & Johnson

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Remote or New Brunswick, New Jersey, 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 4 days ago | Updated 2 hours ago

LIMS and QC Applications Consultant

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
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Posted 60+ days ago | Updated moments ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree
Posted 13 days ago | Updated 2 hours ago

Veeva Presales Consultant

NexInfo Solutions, Inc.

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Remote

Contract

Title: Veeva Presales ConsultantLocation: Remote Client Engagement & SolutioningEngage with potential clients to understand their business challenges, current system landscape, and digital transformation needs.Lead discovery sessions to gather functional and technical requirements relevant to Veeva Vault solutions (e.g., Veeva CRM, Vault Quality Docs, RIM, eTMF, PromoMats, etc.).Articulate the value proposition of Veeva products and services in the context of customer-specific use cases.Content
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Posted 30 days ago | Updated 7 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 29 days ago | Updated 2 hours ago

Aveva / OSIsoft PI Integration AWS Developer

U.S. Tech Solutions Inc.

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Remote

Contract

Location: 100% Remote Duration: 12 Months Job Description: Seeking a hand-on and experienced Senior Developer with 5+ years of experience in core AWS services. They will work with the team to design, build, and apply best practices. Key Responsibilities: The ideal candidate will have strong programming skills with extensive experience in AWS services.Design and implement back-end services using AWS lambda, Glue, Step Functions, API Gateway, S3, Aurora Postgres, Event Bridge and CloudWatch.Exper
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Posted 6 days ago