computer system validation csv engineer jobs

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. Author 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

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 suppo

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

Full-time

Sr/Lead DeltaV Automation Engineer

Muskegon, Michigan

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Yesterday

Job Title : Sr/Lead DeltaV Automation Engineer Location: Muskegon, MI (Onsite) Job Type : Contract Work Authorization: (H1B/ EAD/L2 EAD/EAD) Role Responsibilities: Technical ownership for the projectAct as the primary automation representative in cross-functional program leadership meetings, ensuring alignment between automation, process engineering, digital/MES, and quality teamsServe as the key point of contact for client stakeholders and senior leadership regarding automation scope, progress,

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Contract, Third Party

Depends on Experience

Validation Engineer

Hillsboro, Oregon

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Yesterday

Job Title: Validation Engineer IIWork Location: Hillsboro, OR Computer System Validation Contractor Must haves: Good knowledge of Food and Drug Administration regulations/guidance (or Annex) Effective communicator with excellent verbal and written communication skills - will need to build & maintain good working relationships. Core responsibilities: - Be responsible for the review of system documentation according to the client CSV SOPs and regulatory guidance. Develop plans and reports such as

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Contract

Depends on Experience

IT CSV Manager

Durham, North Carolina

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20d ago

We are seeking an experienced and highly motivated CSV Implementation Lead to drive the successful deployment and integration of enterprise systems including Dynamics 365, LIMS, POMS, MES, and other automation and data management platforms at a major life sciences/biotech site in the Raleigh, NC area. This is a 100% onsite role with a strong emphasis on leadership, mentoring, and capability-building of internal teams, reporting directly to the CSV/QA Manager. Required Skills & Qualifications: Mi

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Contract, Third Party

Depends on Experience

Computer Systems Validation Engineer

Bethlehem, Pennsylvania

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Today

Job Description: We're seeking an experienced Computer Systems Validation (CSV) professional to join our team and lead end-to-end validation activities supporting laboratory system upgrades and data integrity initiatives. This role is ideal for someone with a strong background in regulated environments and hands-on experience with modern lab software and instrumentation. This is a short-term contract assignment running through September and requires individuals to work onsite. Responsibilities

Full-time

System Validation Engineer

Santa Clara, California

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Today

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi

Full-time

Project Manager with IQMS or DELMIAworks Experience - G

Hybrid in Boyertown, Pennsylvania

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Yesterday

Project Manager with IQMS or DELMIAworks Experience, Boyertown, PA We a seeking a Project Manager for a great opportunity in Boyertown, PA. The Project Manager in this position is to report to and receive directions from the Director, Information Technology. The role is based in Boyertown, PA, and requires 3 days Onsite (Tuesday, Wednesday, Thursday). Willingness and ability to travel up to 25% (1-2 times every 2 months). Project Manager Responsibilities: - The Project Manager will manage the

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Full-time

$130,000 - $150,000

CSV Lead

King of Prussia, Pennsylvania

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Yesterday

Job Description: Pay Range: $65hr - $70hr 12+ years Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterfall methodology-based software development Compliance and ha

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Contract

$65 - $70

SAP Validation Lead

Foster City, California

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Today

We are seeking an experienced SAP Validation Lead to drive Computer System Validation (CSV) efforts for SAP systems in a regulated environment. The ideal candidate will ensure SAP implementations and enhancements comply with GxP, FDA 21 CFR Part 11, Annex 11, and industry validation standards. This role requires deep expertise in SAP validation, SDLC methodologies, risk-based validation approaches, and change management processes. You will collaborate closely with Business, IT, QA, and Regulator

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Third Party, Contract

Depends on Experience

Senior Staff, Software Quality Assurance Engineer

Portage, Michigan

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Today

Work Flexibility: Hybrid Senior Staff, Software Quality Assurance Engineer Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including FDA, HIPAA, ISO, and SOC 2. Work Flexibility: Hybrid: Candidates must resi

Full-time

Senior Engineer / Equipment Qualification

No location provided

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Today

Job Description Summary This position will be located at East Hanover, NJ site and will not have the ability to be located remotely. "Please note that this role would not provide relocation and only local candidates will be considered." The Equipment Qualification Engineer is responsible to ensure the qualification program for facilities, utilities, equipment and analytical instrumentation at the Novartis, Cell and Gene Therapy East Hanover, NJ facility is executed in accordance with internal p

Full-time

USD 114,100.00 per year

CSV Engineer

Santa Clara, California

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Today

Job Description: The CSV Engineer will play a critical role in ensuring that all computerized systems used in the manufacturing and quality systems of medical devices are validated according to applicable regulations such as FDA 21 CFR Part 11, EU Annex 11, and ISO 13485. This role ensures the systems are compliant, reliable, and fit for intended use, supporting quality and regulatory requirements across the organization. Responsibilities: Develop and execute Computer System Validation (CSV) de

Full-time

Medical Device Engineer

North Chicago, Illinois

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Today

Full-time

Medical Device & Regulations Engineer

Santa Clara, California

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Today

Full-time

GMP Tester / Validation Engineer

Vacaville, California

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Today

Job Description: We are seeking a skilled GMP Tester / Validation Engineer with strong experience in testing and validating applications in regulated environments (GMP, GxP, Pharma, Life Sciences). The ideal candidate will have hands-on expertise in validation testing, documentation, and compliance for critical applications such as MES, LIMS, ArchestrA, and manufacturing systems. This role requires a detail-oriented professional who can design and execute validation tests, review traceability

Full-time

CSV Engineers

Thousand Oaks, California

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Yesterday

Title: CSV Engineers Location: Thousand Oaks, CA | Onsite Duration: Contract Summary: The CSV Engineers must be experts in systems configuration, validation, and data integrity. The team will be testing SAP lot numbers into systems to prove that numbers are translated, propagated, and processed correctly through the systems (SCADA, DeltaV, and InMation). The team will use Kneat, any prior experience with this platform is helpful but not required. Top Requirements: BS degree minimum 5+ years of C

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Contract

Depends on Experience

CSV Consultant

King of Prussia, Pennsylvania

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Today

JD 12+ years Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System V

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Third Party, Contract

$60 - $60

Software Quality Engineer

Secaucus, New Jersey

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Today

Job Description The Software Quality Engineer (SQE) within Quality and Regulatory organization plays a critical role in ensuring that software whether embedded in products, supporting clinical workflows, or used in enterprise quality systems meets rigorous internal quality standards and global regulatory requirements. The SQE is responsible for driving and executing software validation activities across the development lifecycle, contributing to design control, risk management, and audit readi

Full-time

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computer system validation csv engineer jobs