GAMP jobs in Remote

Hybrid in Raritan, New Jersey

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3d ago

Role CSV Validation Lead Location -Raritan, NJ(Hybrid) Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry. Experience in FDA and/or Global regulated environment with good understanding of GxP standa

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Contract

Depends on Experience

GxP Project Manager (Pharma)

Hybrid in San Francisco, California

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4d ago

Job Title: GxP Project Manager Location: Bay Area, CA Duration: 6+ months with possible of extension Required Qualifications Bachelor's degree in Engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field.8+ years of Project Management experience within the Pharmaceutical or Biotechnology industry.5+ years managing GxP-regulated projects.Strong understanding of GMP, GxP, GAMP 5, FDA regulations, and 21 CFR Part 11.Experience managing Computer System Validation (CSV)

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Third Party, Contract

$80 - $90

CSV Consultant(Computer System Validation ? GenAI, Agentic , SAP

Raritan, New Jersey

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Today

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Contract

USD45.0/HOURLY - USD52.0/HOURLY

CSV Lead

Hybrid in Raritan, New Jersey

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Today

About Us: CodeForce 360 is a trusted global IT talent partner helping Fortune 500 companies, system integrators, and enterprise organizations build high-performing technology teams. With over 16 years of industry expertise, we combine speed, precision, and market intelligence to deliver exceptional talent across today's most in-demand technologies. About the Job- We are looking for an experienced CSV Lead to join one of our enterprise client engagements. The ideal candidate should have st

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Contract, Third Party

$47 - $52

IT / CSV Specialist

San Juan, San Juan

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Today

PACIV, a global leader in industrial automation solutions servicing the Life Sciences sector, is seeking a IT / CSV Specialist to provide technical support for laboratory applications, systems, infrastructure, and validation activities within a pharmaceutical manufacturing environment. Position Responsibilities / Essential Functions:Provide IT support for laboratory applications such as Empower, SmartLab, and Darwin LIMS.Perform user administration, troubleshooting, and support for laboratory s

Full-time

DeltaV Batch Engineer

Muskegon, Michigan

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Today

ole:DeltaV Batch Engineer Location:Muskegon, MI Employment Type:Contract W2 Job Description: Role requires a senior level automation engineer comfortable operating independently while supporting others.No CSV authorship responsibility: CSV activities are supported indirectly through automation execution and issue resolution.DeltaV DCS automation experience in pharmaceutical / biopharma manufacturing (DeltaV Batch experience is a must, not Continuous DeltaV)Strong troubleshooting and problem sol

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Contract

Depends on Experience

Computer System validation Engineer

Wilmington, Delaware

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Today

Hi, Title:Computer System validation Engineer Compute System Validation(CSV) with R&D Knowledge Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system Knowledge, Experience and Skills: { CORE CSV 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic r

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

CSV Lead

Hybrid in Raritan, New Jersey

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Today

Job Title: CSV Lead Location - Raritan, NJ (Hybrid) W2/C2C Mandatory Skills - LIMS Lab Vantage & CSV Job Summary: Experience in the Pharmaceutical, biotechnology with LIMS Labvantage related System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidances and industry standards (i.e., GAMP) Experience in writing and executing documentation for all as

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Contract, Third Party

55 - 60

Automation Commissioning Engineer

Sanford, North Carolina

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Today

Description: The Automation Commissioning Engineer is responsible for leading the commissioning, startup, troubleshooting, and turnover of GMP automation systems supporting pharmaceutical manufacturing operations. This role serves as the technical lead for automation commissioning activities, working closely with system integrators, engineering, validation, quality, IT/OT, and equipment vendors to ensure automation systems are safely commissioned, fully functional, and ready for qualification an

Full-time

Automation SME

Gaithersburg, Maryland

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20d ago

Catalyx is seeking an Automation Subject Matter Expert (SME) provides technical leadership for the design, implementation, validation, and lifecycle support of automation systems supporting biologics manufacturing operations. This role ensures automation solutions are reliable, compliant, secure, and aligned with industry standards while supporting upstream and downstream process performance. The SME works closely with engineering, manufacturing, quality, validation, and system integration teams

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Contract

140,000 - 170,000

POMS Techno functional SME

Albany, New York

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25d ago

Role name: POMS Techno functional SME Work Location Albany, New York (On Site) Duration: 12+ Months Role Overview: Role POMS Techno functional SME Experience 8 to 12 Years Domain: Life Science/Pharma & MES Location: Albany, New York (onsite candidates preferred) Job Description: Experienced POMS MES Techno-Functional SME with strong expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical environment. The candidate will act as a bridge between business stakeho

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Third Party, Contract

Depends on Experience

CSV Consultant

Hybrid in Raritan, New Jersey

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19d ago

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI/Agentic AI in a GxP-regulated environment. The ideal candidate will have strong experience validating enterprise applications while ensuring compliance with FDA and global regulatory standards. Key Responsibilities: Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications.Develop and execute validation documentation, including Valida

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Contract

45 - 50

Reliability Engineer

Boston, Massachusetts

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Today

Job Title Reliability Engineer Job Description Summary This individual will provide support for Facility Operations/Engineering department sites as part of the Reliability Engineering team. The ideal candidate will be responsible for ensuring the reliability and performance of our equipment/systems through Reliability best practices and continuous improvement initiatives. This role will also execute documentation/forms/spreadsheets to roll out Maintenance and Reliability Best Practices for new

Full-time

USD 52.70 - 62.00 per hour

Process Automation Engineer (DeltaV)

Calabasas, California

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Today

Wunderlich-Malec Engineering (WM) is a 100% employee-owned ESOP and one of the largest and most well-established engineering companies in the United States. When you join WM you become part of a company that is: 100% employee-owned with 40+ years of industry historyENR (Engineering News Record) Top 500 firmRated as a top System Integrator Giant We have a Process Automation Engineer position open in Calabasas, CA. This position is responsible for designs, implements, and maintains process automat

Full-time

USD 120,000.00 - 180,000.00 per year

Controls Engineer II, Operational Technology

Silver Spring, Maryland

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Today

California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop

Full-time

USD 84,000.00 - 120,000.00 per year

EV Engineer III

Bedford, Ohio

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Today

Job Title: Equipment Validation Engineer Location: Bedford, Ohio Job Type: Full-Time Req ID: 11964 Summary The Equipment Validation Engineer plays a key role in supporting a sterile pharmaceutical manufacturing facility through the qualification and lifecycle management of manufacturing equipment, utilities, and associated systems. This position leads equipment qualification and change-based revalidation activities, supports manufacturing investigations, and collaborates with Operations, Engin

Full-time

USD 59,900.00 - 120,450.00 per year

Engineer, Automation

Maryland

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Today

Automation Engineer Position Summary: Work Schedule: Monday - Friday, 8am - 5pm. 100% on-site Catalent's Baltimore and Harmans, Maryland sites provide industry-leading GMP development and manufacturing services for advanced biopharmaceuticals, including viral vectors, next-generation vaccines, and oncolytic viruses. Our FDA-licensed, state-of-the-art Gene Therapy manufacturing campus in Harmans/BWI features two facilities located just five miles from BWI Airport and 13 miles from downtown Balt

Full-time

USD 80,000.00 - 110,000.00 per year

Validation Engineer II

New York

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Validation Engineer II Grand Island, NY | On-site - Relocation assistance is not available. Candidates must be legally authorized to work in the United States without sponsorship. Employment is contingent upon successful

Full-time

USD 70,000.00 - 86,000.00 per year

CQV Engineer

Portland, Maine

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Today

Summary: Seeking a CQV Validation Engineer with 5+ years of experience in pharmaceutical, biotech, or life sciences. The ideal candidate will have hands-on experience with Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment. Roles & Responsibilities: Perform CQV activities for standalone equipment. uthor and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning, qualification, and validat

Full-time

Senior Automation Systems Administrator, Manufacturing & Lab Support

Menands, New York

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Today

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Automation Systems Administrator to join our IOPS team, providing expertise in the configuration and administration of automated and computerized system software and firmware across our manufacturing and laboratory operations. In this role, you will ensure systems remain in a compliant and validated state - leading projects, driving

Full-time

USD 78,700.00 - 128,700.00 per year