GAMP Jobs

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Utilities Automation Engineer

Amgen Inc

•

West Greenwich, Rhode Island, USA

Full-time

Career Category Operations Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients eac
Posted 19 hours ago | Updated 7 hours ago

CSV LEAD CONSULTANT

Nityo Infotech Corporation

•

King of Prussia, Pennsylvania, USA

Contract, Third Party

Mandatory Skills: CSV, Compliance and Assurance services, LIFE-SCIENCES (GXP FDA CSV IQ/OQ/PQ), Veeva, Argus, Defect Tracking Tools JIRA Primary Skill: Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management Secondary Skil: JIRA Veeva Argus Agile and Waterfall methodology 10+ years Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review
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Posted 1 day ago

MES Engineer (Syncade)

Zachary Piper Solutions, LLC

•

Holly Springs, North Carolina, USA

Full-time

Piper Companies is hiring a MES Engineer (Syncade) for a biomanufacturing hub locate din Holly Springs, NC. The MES Engineer (Syncade) will be supporting the integration and configuration of Emerson DeltaV MES for two manufacturing facilities, ensuring compliance with cGMP standards and paperless workflows. The MES Engineer (Syncade) is a long term contract opportunity and will require the candidate to work on site in Holly Springs, NC 4 days per week. Responsibilities of the MES Engineer (Sync
Posted 16 hours ago | Updated 5 hours ago

Manufacturing/Production Technician (GMP/Pharma/Lab)JK

Cube Hub, Inc.

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Redwood City, California, USA

Contract

Job Title : Manufacturing Technician Location : Redwood City, CA, 94063 Duration : 12 months Contract-possible to extend Shift Details : 2nd shift- 1:30 pm to 10 Pm Pay Range : $23/hr. - $25/hr. Job Description: Supports production line by conducting routine tasks which may include setting up, taking down, cleaning and undertaking the routine maintenance of operating equipment, as instructed, to ensure continued production. Typical Accountabilities: Conduct activities and interactions consi
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Posted 23 hours ago | Updated 15 hours ago

Electrical/Automation SME

Zachary Piper Solutions, LLC

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Bloomington, Indiana, USA

Full-time

Piper Companies is seeking a BioPharma Electrical/Automation Subject Matter Expert (SME) to manage the construction and communication of a new facility build for a CDMO out in Bloomington, IN. The role has an onsite expectation and slated through 2026 and potentially beyond. The SME will provide technical leadership and subject matter expertise throughout the design, construction, commissioning, and qualification of a new pharmaceutical manufacturing facility. This role will be responsible for e
Posted 3 days ago | Updated 5 hours ago

MES Engineer

TSR Consulting Services, Inc.

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Summit, New Jersey, USA

Contract

Our client, a leading pharmaceutical company, is hiring a MES Engineer, on a contract basis. Job ID #: 82365 Work Location: New Brunswick, NJ - 50% on site Summary: 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. Youll
Posted 15 days ago | Updated 4 hours ago

Equipment Engineer

TSR Consulting Services, Inc.

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Warren, New Jersey, USA

Contract

Our client, a leading pharmaceutical company, is hiring an Equipment Engineer, on a contract basis. Job ID #: 82207 Work Location: Warren, NJ - 100% on site Summary: The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers. The incumbent conducts tasks assigned by the management independently or with minimum supervision
Posted 38 days ago | Updated 4 hours ago

MES Engineer

Sunrise Systems, Inc.

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Summit, New Jersey, USA

Contract

Job Title: MES Engineer Job ID: 25-07988 Location: Summit, NJ Duration: 06 Month s Contract on W2 Candidates must be onsite 50% of the time at either Summit West, Giralda Farms, Princeton Pike, Lawrenceville, or New Brunswick. Must Have List4+ years of Computer System Validation (CSV) experience in regulated pharmaceutical and biotech environments, with strong knowledge of GAMP 5, 21 CFR Part 11, and Computer Software Assurance (CSA) principles.3+ years of hands on MES experience with Emerson S
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Posted 15 days ago | Updated 1 day ago

QC Laboratory Analyst (32376)

Myticas LLC

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Worcester, Massachusetts, USA

Contract

Myticas' direct client is seeking an IT Systems/Laboratory Analyst- Hypid at Worcester, MA (4 days onsite at Worcester, MA). Duration: 6+ Months Contract (Possible further extension) Top Skills/Experience Requirements: Familiarity and experience installing Acronis, Crowd strike( antivirus software), patchlab. Strong communication skills Strong excel macros and excel skills. Medium proficiency in Power platforms Decommissioning computer systems. GMP experience Job Description Summary: Responsi
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Posted 4 days ago | Updated 4 hours ago

MES/Manufacturing Specialist

Dynamic Enterprise Solutions Inc

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Worcester, Massachusetts, USA

Contract, Third Party

Purpose: Responsible for the provision of technical support for all IT/BTS (Business Technology Solutions) systems, activities, development, and administration of plant IT systems supporting manufacturing operations. Manages and implements projects that affect the manufacturing infrastructure, plant systems, security, workstations, support, and IT standards. Responsibilities: Work on AbbVie IT manufacturing systems and application projects.Is responsible for the implementation and rollout of new
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Posted 29 days ago

MES - Validation Engineer

HAYS

•

Princeton, New Jersey, USA

Contract

MES - Validation Engineer - Contract - Princeton, NJ - $59.44 - $59.44/hr. The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Sponsorship not available. Our client is seek
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Posted 7 days ago | Updated 4 hours ago

Quality Control Laboratory Analyst

Dynamic Enterprise Solutions Inc

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Worcester, Massachusetts, USA

Contract, Third Party

Purpose: Responsible for the provision of technical support for all IT/BTS (Business Technology Solutions) systems, activities, development, and administration of plant Quality Control (QC) and IT systems as well as similar scope on manufacturing operations Supports all hands-on projects that affect the lab and manufacturing IT infrastructure, systems, security, workstations, support, and IT standards. Responsibilities: Work on AbbVie IT QC systems and application projects.Work on AbbVie IT manu
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Posted 29 days ago

SAP Quality Business System Analyst

Visionary Integration Professionals

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Billerica, Massachusetts, USA

Full-time

Visionary Integration Professionals (VIP) provides industry-leading management consulting, system integration, and technology deployment solutions. VIP helps its clients strengthen mission outcomes by combining deep industry specialization, agility to adapt as needed, and an unwavering commitment to client satisfaction. VIP brings expertise in how to deploy systems that align people, processes, and technology to accelerate strategic change and to deliver business results in partnership with its
Posted 60+ days ago | Updated 8 hours ago

C&Q Engineer - (Commissioning & Qualification) || Harrisburg, PA (Onsite)

Stellent IT LLC

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Harrisburg, Pennsylvania, USA

Contract, Third Party

Position: C&Q Engineer Location: Harrisburg, PA (Onsite) Duration: 12+ month contract Multiple Openings - Standard C&Q profile ideally with 7+ years' experience. More experience the better Job Description :- We are looking for a highly skilled Senior Commissioning & Qualification (C&Q) Engineer to support our Life Sciences projects. The ideal candidate will have extensive experience in qualification and validation activities, ensuring compliance with industry regulations and best practices.
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Posted 45 days ago | Updated 11 hours ago

Lead, Technology Compliance

Johnson & Johnson

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Remote or Raritan, 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 2 days ago | Updated 7 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 2 days ago | Updated 7 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Hartford, Connecticut, USA

Full-time

Responsibilities: Functional requirement specification, function risk assessment, installation qualification, operational. Qualification, performance qualification, traceability matrix, project release notes, system certification summary). Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP. Preparing risk assessment for functional requirements and providing testing strategy, implementing technical & procedural controls as part of mitigat
Posted 2 days ago | Updated 7 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Framingham, Massachusetts, USA

Full-time

Responsibilities: Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP. Preparing trace matrix to ensure requirements are tested to meet the software intended use. Preparing risk assessment for functional requirements and providing testing. strategy, implementing technical & procedural controls as part of mitigation. Preparing SOP/Work instruction for equipment and software-based systems. Requirements: 6 to 8 years of Non-Product Software
Posted 2 days ago | Updated 7 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Raritan, New Jersey, USA

Full-time

Role & Responsibilities: 3-7 years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area. Has working experience in any one or two of the following domains Tool validation like ServiceNow, Automation tools, JIRA . Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC. pplication of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 2
Posted 2 days ago | Updated 7 hours ago

Automation Engineer, Delta V

Johnson & Johnson

•

Wilson, North Carolina, 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 7 hours ago