Validation (CQV) Engineer

BioPharma Consulting JAD Group; College Station (TX); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Administrative shift

1-year contract

Job summary

BioPharma Consulting JAD Group seeks a Validation Engineer to lead lifecycle activities for product launches and technology transfers at the FDBT site. You will execute CD/CQ/PQ/PR, collaborate with cross-functional teams, and ensure right-first-time validation aligned with regulatory needs.

The role requires strong technical writing, on-site availability, and expertise in validation documentation and vendor oversight. Proficiency in Kneat and Microsoft Office is beneficial.

Qualifications

• Bachelor's degree in Engineering or Science required.
• 7+ years of validation experience in life sciences.
• Experience creating full validation lifecycle documentation.
• On-site role with no remote work.

Responsibilities

• Execute validation lifecycle activities (CD/CQ/PQ/PR).
• Develop and review URS, FRS, DS, IQ/OQ/PQ protocols.
• Coordinate vendor validation activities and deviations.
• Produce final validation reports and summaries.

Skills

Cross-functional leadership

Technical writing

Project planning

CSV knowledge

Regulatory understanding

Independent troubleshooting

Multitasking

Mentoring teammates

Education

Bachelor's degree in Engineering or Science

Tools

Kneat electronic validation

Word

Excel

PowerPoint

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

Requirements

Education Requirements

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

Benefits

• Administrative shift
• 1-year contract with possible extension