Computer system validation CSV Manager jobs

Computer Systems Quality Assurance (CSQA) with Validation (CSV)

Indianapolis, Indiana

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23d ago

Job Title: Computer Systems Quality Assurance (CSQA) with Validation (CSV) Location: Indianapolis, IN (Onsite) Duration: 12+ Months Job Description: Please not that 1 F2F round is mandatory. Mandatory skills: IT CSV Validation of IT systems IT QA / QA eCompliance Manager Experience with Veeva Quality Docs, ServiceNow, JIRA and HP ALM Pharma industry experience is mandatory Medical device experience is good to have This Computer Systems Quality Assurance role will be responsible for supporting

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Full-time, Third Party, Contract

$DOE

Computer System Validation Engineer

New Jersey

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Today

Roles & Responsibilities: Bachelor's degree in computer science, Engineering, Life Sciences, or related field. 3-7 years of experience in CSV within pharmaceutical, biotech, or medical device industries. Strong knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, and related guidelines. Experience with ERP, LIMS, MES, or other GxP systems. Extensive Experience in HPALM with Manual testing. Deep knowledge in Defect Management Life cycle. Proficient in writing validation protocols, reports, and SOPs

Full-time

Computer System Validation Engineer

Bothell, Washington

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Today

Job Description: The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Contractor has primary responsibility to ensure that the tasks supp

Full-time

CSV Engineer Spring Co-Op

Wilson, North Carolina

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Today

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

Full-time

Lead/Sr Computer System Validation Engineer

Muskegon, Michigan

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Today

Responsibilities: The CSV Lead manages quality control checks on engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible to assist Client in designing the validation strategy for the overall project and to coordinate production of the required CSV protocols. The CSV Lead will provide leadership to the CSV team members in reviewing CSV protocols for the various streams and

Full-time

PL - AS400 Data Analyst /Developer

No location provided

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Today

Job Summary We are seeking an experienced AS400 Data Analyst / Developer to analyze and interpret data extracted from the AS400 (iSeries) environment. The role involves reviewing a flat file generated from an AS400 export to determine its structure, quality, and usability for supporting business operations, reporting, and downstream systems. Key Responsibilities Analyze flat files exported from AS400 to understand data structure, mapping, and relationships. Validate data accuracy, completeness,

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Contract, Third Party

Software Validation Engineer

Plymouth, Minnesota

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Today

Roles & Responsibilities: Bachelor's degree in computer science, Information Technology, Electronics Engineering, or a related field. Minimum 5-8 years of experience in software validation, preferably within the medical device, pharmaceutical, or regulated healthcare industries. Strong understanding of software development lifecycle (SDLC) methodologies, validation planning, risk management, and quality assurance principles. Experience in handling SW development and verification tools. Good exp

Full-time

Empower CDS administration

Greenfield, Indiana

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23d ago

Job Title: Empower CDS administration/ support Location: Greenfield, IN(Relocation is fine) Duration: Long term contractEducational Qualification*Any Bachelor's DegreeExperience Range8-12 yearsPrimary (Must have skills)* - To be Screened by TA Team3+ years of hands-on experience in Empower CDS administration and support. 3+ years of experience on HPLC/UPLC and other analytical instrument integration. 3+ years of experience on Computer System Validation (CSV) and preparation of validation deliv

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Full-time

$80,000 - $100,000

CSV Engineer

San Francisco, California

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Today

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Roles & Responsibilities: 10Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnol

Full-time

Empower CDS administration / support

Greenfield, Indiana

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10d ago

Job Title: Empower CDS administration/ supportLocation: Greenfield, INDuration: Long term contract/Full time Open Educational Qualification*Any Bachelor's DegreeExperience Range8-10 yearsPrimary (Must have skills)* - To be Screened by TA Team3+ years of hands-on experience in Empower CDS administration and support. 3+ years of experience on HPLC/UPLC and other analytical instrument integration. 3+ years of experience on Computer System Validation (CSV) and preparation of validation deliverable

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Third Party, Contract

Depends on Experience

Validation/Test Lead & Testers Regulated Systems (Veeva / SQM / QRM)

Remote

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Today

Job Title: Validation/Test Lead & Testers Regulated Systems (Veeva / SQM / QRM) Position Summary We are seeking experienced Validation/Test professionals-including a Validation/Test Lead and multiple Testers-to support a large-scale Veeva Quality implementation within a regulated (GxP) environment. The ideal candidates will have hands-on experience with Computer System Validation (CSV) processes, creation and execution of regulated validation deliverables, and a strong understanding of Suppli

Contract, Third Party

Verification Support Engineer

Louisville, Kentucky

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Today

Roles & Responsibilities: Pharmacy Verification Support engineer for a minimum of 4 years. Working knowledge of software or system validation in regulated industry like Medical Device or Pharma. Strong knowledge and experience of computerized system development life cycle (SDLC) approaches and validations strategies is required. Experience with COTS/Custom made Analytical Instrument and experience working in QC Laboratories, R&D, manufacturing/operations is required. Software Quality Engineer (S

Full-time

IT Manager

No location provided

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9d ago

Position:IT Manager Location:Lake Forest, IL (Onsite with some flexibility) Duration:Contract-to-Hire Job Summary: We are seeking a hands-on IT Manager with a strong background in life sciences to oversee IT operations, infrastructure, vendor management, and regulatory compliance. This role requires technical expertise along with leadership to drive secure, validated systems in a regulated environment supporting R&D, Quality, Clinical, and Commercial teams. Must-Have: Strong technical background

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Contract

80 - 90

Engineer III, Automation Engineering

Cincinnati, Ohio

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Location/Division Specific Information Thermo Fisher Scientific Inc. is currently seeking a Engineer , Automation Engineering for our Cincinnati facility. By joining our team, you will have the opportunity to make a tangible difference and receive the appropriate support needed to accomplish your professional aspirations. How will you make an

Full-time

Senior CSV Engineer

Remote or Massachusetts

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Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

Lab Instruments Software Validation Analyst

Highland Heights, Kentucky

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Today

Job Description:NTT DATA's Client is seeking an experienced Lab Instruments Software Validation Analyst with 10+ years of proven expertise in the clinical research industry, including a minimum of 5+ years of hands-on, specialized experience in analytical instrument/software validation and equipment qualification to join their team in Highland Heights, KY. This role ensures the reliability, accuracy, and regulatory compliance of laboratory instrument software and computerized systems used in cl

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Contract

BASED ON EXPERIENCE

Laboratory Information Management System (LIMS) SME

Highland Heights, Kentucky

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Today

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here.For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing se

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Contract

$40 - $49 hr

MES Analyst

San Jose, California

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28d ago

MES Analyst Bay Area, CA - Locals only6+ Months Top Skills: Siemens Opcenter MES and CAMSTAR Manufacturing Consulting Medical DevicesJob Description: A dynamic professional with proven expertise in Siemens Opcenter Medical Devices in Manufacturing Execution domain. Design and architect multi-site MES Opcenter implementation based on discussion with business teams and their processesShould have Experience on LOFTWARE PRISYM 360 Understand the paper Batch record and business process flow in collab

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Contract, Third Party

$60 - $70

Computer System Validation (CSV) Engineer

Remote or Massachusetts

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Today

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

Full-time

Validation Engineer

Raritan, New Jersey

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Today

Job Description: We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems, combined with technical writing/documentation skills. This role is critical in ensuring compliance, validation, and accurate documentation of enterprise applications, particularly in regulated environments (GxP/21 CFR Part 11). Responsibilities: Perform Computer System Validation (CSV) activities for SAP and OpenText systems. Develop and execute validation protocols (IQ, OQ,

Full-time

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Computer system validation CSV Manager jobs