Validation Engineer

GxP Validation Engineer

Computer System Validation (CSV) & Equipment Qualification

Location:

Remote

Employment Type:

Full-time

Department:
Quality / Validation

Reports To:

Validation or Quality Leadership

We are a rapidly growing U.S.

-based life sciences company operating in a highly regulated GxP environment across the pharmaceutical, biopharmaceutical, and medical device space. As we scale our operations, laboratory capabilities, and manufacturing infrastructure, maintaining a fully validated, inspection-ready state is central to how we work.

This is a hands-on, high-ownership environment where quality and compliance are built into the foundation of the business rather than treated as an afterthought. You will join a team that is actively investing in its validation program and the systems that support it.

This role exists to ensure that our GxP systems, equipment, utilities, facilities, and processes are properly qualified, validated, and maintained in a validated state throughout their lifecycle. As the organization grows, we need someone who can both execute validation activities and help mature the program behind them — building and maintaining the plans, procedures, and documentation that keep us audit-ready.

It is a genuinely hybrid position spanning two disciplines that are often held separately: equipment, utility, and facility qualification (CQV) on one side, and Computer System Validation (CSV) on the other. You will work independently while partnering closely with Subject Matter Experts, Quality Assurance, IT, Engineering, Manufacturing, Laboratory, and Facilities to define requirements, set acceptance criteria, and drive validation activities to completion.

• Support the development and implementation of validation strategies aligned with the ISPE C&Q Baseline Guide (2nd Edition), FDA expectations, and internal policies and procedures.
• Contribute to and maintain Validation Master Plans (VMPs) and project-level validation plans.
• Participate in system impact assessments and equipment classification.
• Apply a risk-based approach across all qualification and validation activities.

• Develop, review, and execute qualification documentation, including Design Review (DR), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Author and maintain requirements specifications (URS/SRS), traceability matrices, and qualification summary reports.
• Leverage vendor documentation appropriately to streamline qualification without compromising compliance.
• Execute temperature mapping and utility system qualification activities.

• Plan and execute process validation and cleaning validation activities for GxP manufacturing operations.
• Define acceptance criteria and critical process parameters in collaboration with SMEs.
• Support requalification and periodic review activities to maintain validated status.

• Plan, develop, review, and execute CSV activities for GxP computerized systems, including standalone applications, configured and customized applications, laboratory systems, equipment software, and system interfaces.
• Develop and maintain risk-based CSV lifecycle documentation: validation plans, user and system requirements, functional and configuration specifications, risk assessments, IQ/OQ/PQ protocols and test scripts, traceability matrices, validation summary reports, and periodic reviews.
• Assess systems for regulatory and data integrity requirements, including 21 CFR Part 11 and electronic records / electronic signatures (ERES).
• Evaluate access controls,…