GxP Validation Engineer

Computer System Validation (CSV) & Equipment Qualification

Location: Remote

Employment Type: Full-time

Department: Quality / Validation

Reports To: Validation or Quality Leadership

About the Company

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.

About the Role

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.

Key Responsibilities

Validation Strategy & Planning

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.

Equipment, Utility & Facility Qualification (CQV)

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.

Process & Cleaning Validation

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.

Computer System Validation (CSV)

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, security, audit trails, electronic signatures, record retention, and backup/recovery controls.

Documentation, Compliance & Data Integrity

Produce accurate, complete, audit-ready documentation compliant with GxP requirements.
Create and maintain the VMP, process flow diagrams, and standard operating procedures (SOPs).
Uphold data integrity principles (ALCOA+) across all validation deliverables.
Document critical aspects and risk-mitigation controls clearly and defensibly.

Change Control & Lifecycle Management

Manage deviations arising during qualification and validation activities.
Support change control assessments and determine the impact of changes on validated systems.
Conduct risk assessments to identify and mitigate potential validation issues.

Required Qualifications

Bachelor's degree in engineering, computer science, a life science, or a related field.
Minimum of 5 years of equipment qualification and validation experience in the pharmaceutical, biopharmaceutical, or medical device industry.
Minimum of 3 years of Computer System Validation experience.
Hands-on experience across equipment and systems validation, cleaning validation, process and utility validation, laboratory systems and equipment, temperature mapping, and manufacturing equipment qualification.
Experience validating GAMP 5 Category 4 and 5 software systems.
Working knowledge of 21 CFR Part 11 and electronic records / electronic signatures requirements.
Strong command of GAMP 5 principles, the ISPE C&Q lifecycle approach, and data integrity principles (ALCOA+).
Exceptional technical writing skills, with a track record of producing audit-ready validation documentation.

Preferred Qualifications

Experience building validation programs from the ground up — authoring VMPs and SOPs, not only executing against existing ones.
Direct experience supporting FDA inspections or regulatory audits.
Experience with automated testing frameworks for computerized systems.
Strong project management skills, with the ability to balance multiple concurrent validation activities.

Ideal Candidate Profile

You are:

Genuinely fluent in both equipment/facility qualification and computer system validation — comfortable moving between the two rather than specializing in only one.
A self-directed operator who can own validation deliverables end to end with minimal oversight.
A meticulous documenter who treats audit-readiness as a default, not a scramble before an inspection.
A clear cross-functional communicator who can pull technical and process detail out of SMEs across QA, IT, Engineering, Manufacturing, Lab, and Facilities.
A risk-based thinker who knows where to focus rigor and where to move efficiently.

Why Join Us

You will play a central role in keeping a growing life sciences operation compliant, inspection-ready, and built to scale. This is a rare opportunity to work across the full validation landscape — equipment, utilities, facilities, processes, and computerized systems — and to help shape the program itself, not just work within it.

Validation Engineer - 21290