computer system validation csv associate Jobs in bridgewater, nj

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Computer System Validation CSV EngineerJob Title - Computer System Validation CSV Engineer

VetForce SolutionsCompany Name - VetForce Solutions

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Raritan, New Jersey, USA

Contract, Third Party

Role - Computer System Validation CSV Engineer Location - Raritan, NJ(Hybrid) Job Details: 7-10 years experience in Computer System Validation SAP ECC/S4, SolMan/ChaRM Change Control process Experienced in computer systems validation, GXP regulatory knowledge and good documentation methods and CSA approaches and risk-based validation. Knowledge in utilizing SDLC tools such as JIRA, qTest, X-ray, test automation tools and methods, Proficient knowledge on CFR Part 11 regulations and Quality Manag

Computer System Validation EngineerJob Title - Computer System Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V

Computer System Validation Analyst - R Studio & Clinical SystemsJob Title - Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and LifesciencesCompany Name - 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

Benchling Technical Support Specialist (GxP / CSV Experience Preferred)Job Title - Benchling Technical Support Specialist (GxP / CSV Experience Preferred)

Infinite Computer Solutions (ICS)Company Name - Infinite Computer Solutions (ICS)

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Remote

Third Party, Contract

Job Summary: We are seeking a skilled and proactive Technical Support Specialist with hands-on experience supporting Benchling, a leading cloud-based platform for life sciences R&D. The ideal candidate will have a strong background in providing technical application support within a regulated GxP environment, and exposure to Computer System Validation (CSV) is highly desirable. The role requires close collaboration with the client s IT and Quality teams to ensure consistent and compliant system

Software Validation Quality Consultant | Contract, W2Job Title - Software Validation Quality Consultant | Contract, W2

Alpha Business Solutions LLCCompany Name - Alpha Business Solutions LLC

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Nutley, New Jersey, USA

Contract

Our direct client a large pharmaceutical company is seeking to hire a Software Validation Quality Consultant for 6 months plus contract to work hybrid from their Nutley, NJ Job Title: Software Validation Quality Consultant Duration: 6 months plus Location: Nutley, NJ | Hybrid - must be a local candidate willing to come on site at least 2 days a week, with one of them being Wednesday (more, if needed). Looking for someone who has done Validation in the clinical space. Google Cloud Platform and

Pharma Computer Systems Quality Assurance_ Long term contract || RemoteJob Title - Pharma Computer Systems Quality Assurance_ Long term contract || Remote

Accion LabsCompany Name - Accion Labs

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Remote

Third Party, Contract

This Computer Systems Quality Assurance role will be responsible for supporting the expansion of client s ERP systems and associated applications to new and existing manufacturing sites. The role will deliver quality oversight to ensure assigned systems are developed and maintained, in compliance with corporate Computer System Validation (CSV) standards. Key Objectives/Deliverables: Maintain Inspectional Readiness Ensure supported systems are validatedEnsure all quality actions and commitments f

Validation Engineer - (CSV, CSQA)Job Title - Validation Engineer - (CSV, CSQA)

Activesoft, Inc.Company Name - Activesoft, Inc.

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Remote

Contract

Required Skills: IT Computer System Validation (CSV)Must have: Certified Software Quality Analyst (CSQA) certification.

IT infrastructure CSV ConsultantJob Title - IT infrastructure CSV Consultant

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Cranbury, New Jersey, USA

Full-time

Responsibilities: We are seeking a Validation & IT Systems Specialist to join our dynamic team. This role combines expertise in validation and computer system validation (CSV) with IT administrative support for regulated systems and applications. IT Infrastructure guy who has worked in the Pharma industry, having 21 CFR part 11 exp. Provide administrative support for IT systems and applications, ensuring smooth operations in a regulated environment. Manage system configurations, troubleshooting

CSV EngineerJob Title - CSV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Nutley, New Jersey, USA

Full-time

Job Description: Looking for someone who has done Validation.Google Cloud Platform and CSV. Must understand the business of clinical. We are seeking a versatile professional with the ability to review documents meticulously and support the creation of validation deliverables as needed. The ideal candidate will thrive in a challenging environment and possess the skills to effectively communicate the importance of validation processes to stakeholders outside the validation team. Responsibilities:

Validation Lead with SAPJob Title - Validation Lead with SAP

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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South Plainfield, New Jersey, USA

Full-time

Responsibilities: To create| assign and track the project [module] work plans for delivery and provide technical guidance for work completion. Ensure process improvement and compliance in the assigned module| and participate in technical discussions/review. Create work plans| monitor and track the work schedule for on time delivery as per the defined quality standards. Prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations. Develop and guide

CSV Automation Engineer (R3)Job Title - CSV Automation Engineer (R3)

Eli Lilly and CompanyCompany Name - Eli Lilly and Company

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Branchburg, New Jersey, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined

CSV EngineerJob Title - CSV Engineer

Katalyst Healthcares and LifesciencesCompany Name - 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

MES EngineerJob Title - MES Engineer

Sunrise Systems, Inc.Company Name - 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

Commissioning/Qualification Specialist / Specific Commissioning and Validation supportJob Title - Commissioning/Qualification Specialist / Specific Commissioning and Validation support

TSR Consulting Services, Inc.Company Name - TSR Consulting Services, Inc.

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Summit, New Jersey, USA

Contract

Our client, a leading pharmaceutical company, is hiring a Commissioning/ Qualification/ Specific Commissioning and Validation support specialist, on a contract basis. Job ID: 82482 Work Location: Summit, NJ - 50% on site Education/Experience: BS degree in Engineering / Computer Science or equivalent with 2 years of experience OR Associate degree with at least 4 years of relevant experience Competencies: Technical / Professional Knowledge Problem Solving / Troubleshooting Action Oriented Attentio

Commissioning/Qualification Specialist / Specific Commissioning and Validation supportJob Title - Commissioning/Qualification Specialist / Specific Commissioning and Validation support

LOGIXtech SolutionsCompany Name - LOGIXtech Solutions

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Summit, New Jersey, USA

Contract

Data Integrity ManagerJob Title - Data Integrity Manager

TSR Consulting Services, Inc.Company Name - TSR Consulting Services, Inc.

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New Brunswick, New Jersey, USA

Contract

Our client, a leading pharmaceutical company, is hiring a Data Integrity Manager-Quality Assurance, on a contract basis. Job ID: 82494 Work Location: New Brunswick, NJ - 50% on site Summary: The position is in the Global Quality GxP IT Quality Assurance department within the Data Integrity tower. It is responsible for providing support to the Lead of the GxP Data Integrity program across the end-to-end product lifecycle, ensuring that regulatory and company requirements are thoroughly and effec

Data Integrity ManagerJob Title - Data Integrity Manager

LOGIXtech SolutionsCompany Name - LOGIXtech Solutions

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New Brunswick, New Jersey, USA

Contract

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

MES - Validation EngineerJob Title - MES - Validation Engineer

HAYSCompany Name - HAYS

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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

MES EngineerJob Title - MES Engineer

TSR Consulting Services, Inc.Company Name - 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