Validation (CQV) Engineer

BioPharma Consulting JAD Group; College Station (TX); On-site; USD 110,000 - 150,000; Full time

Job summary

BioPharma Consulting JAD Group seeks a Validation Engineer to support product launches, technology transfers, and new tech introductions at the FDBT site. You will drive the validation lifecycle (IQ/OQ/PQ/RQP) and periodic reviews, collaborating with cross‑functional teams while emphasizing right‑first‑time execution and compliance.

The role requires on‑site work in a regulated life sciences environment with 7+ years of experience and a Bachelor’s degree in Engineering or Science.

Qualifications

• Experience creating full validation lifecycle documentation (URS, FRS, DS, specs).
• Knowledge of validation protocols (VPP, IQ, OQ, PQ) and system impact analyses.
• Ability to independently troubleshoot and communicate technical issues.
• Experience leading cross‑functional teams on complex projects.

Responsibilities

• Provide scientific and technical support for product launches and tech transfers.
• Manage IQ/OQ/PQ/RQP execution and associated documentation.
• Coordinate vendor validation activities and review vendor protocols.
• Develop and manage detailed project plans and timelines.
• Write and update SOPs; ensure right‑first‑time execution.

Skills

Validation lifecycle

IQ/OQ/PQ

CSV knowledge

Cross-functional leadership

Documentation

Troubleshooting

Project planning

Vendor management

SOP writing

MS Office

Education

Bachelor's degree in Engineering or Science

Tools

Kneat electronic validation

Data loggers & temp mapping

Laboratory equipment know‑how

Job description

The Validation Engineer is responsible for providing scientific and technical support for product launches, technology transfers, and new technology introductions at the FDBT site. This role executes key validation lifecycle activities—including Cycle Development (CD), Commissioning & Qualification (CQ), Performance Qualification (PQ), and Periodic Reviews (PR)—while collaborating closely with cross‑functional teams across the site and occasionally with network partners. Emphasis is placed on right‑first‑time execution, compliance, and continuous improvement.

Key Requirements

• On‑site role; remote work is not permitted.
• Experience creating full validation lifecycle documentation:
• URS, FRS, DS, engineering specifications
• Validation protocols (VPP, IQ, OQ, PQ)
• System Impact Assessments, Requirements Traceability Matrix, Final Reports
• Strong understanding of validation processes and regulatory requirements.
• Ability to independently troubleshoot, resolve, and communicate technical issues.
• Proven experience leading cross‑functional teams and coordinating complex projects.
• Ability to develop and manage detailed project plans and timelines for IQ/OQ/PQ/RQP execution.
• Working knowledge of Computerized Systems Validation (CSV).
• Support implementation of new process technologies aligned with business and regulatory needs.
• Ownership of vendor‑performed validation activities, including:
• Review and approval of vendor protocols
• Issue resolution
• Validation deviation reporting
• Summary report generation
• Coordinate and execute tactical validation activities:
• Sample collection
• Data retrieval
• Documentation completion per protocol requirements
• Excellent technical writing skills for SOP creation and updates.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to work independently, multitask, and support multiple projects simultaneously.
• Provide guidance and support to junior team members.
• Must be available to work as needed, including holidays and weekends.

Areas of Expertise

• Kneat electronic validation documentation
• Data loggers (pre/post calibration procedures)
• Temperature mapping: cold rooms, freezers, refrigerators, incubators
• Laboratory equipment (e.g., Mass Photometer)
• Autoclaves & cycle development
• EMPQs
• Biowelders
• Culture chemistry analyzers
• Smoke studies
• Fillers
• VHP decontamination & cycle development
• Bioquell Qube
• Mixers, tanks, VCells
• AKTA systems
• Filter integrity testers
• Pumps
• Centrifuges
• Downflow hoods
• Weight scales
• SME Water Systems (WFI, RODI)
• Clean gas utilities
• Facilities systems

Education Requirements

• Bachelor’s degree in Engineering or Science (minimum).
• 7+ years of validation experience in the life sciences industry.

• Administrative shift
• 1-year contract with possible extension