Senior Validation Engineer - CQV/CSV (On-site)

BioPharma Consulting JAD Group; College Station, Northern (TX, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

BioPharma Consulting JAD Group is seeking a Validation Engineer to provide scientific and technical support for product launches, technology transfers, and new technologies at the FDBT site. The role emphasizes right‑first‑time execution, compliance, and continuous improvement.

You will execute key validation lifecycle activities (CD, CQ, PQ, PR) and collaborate with cross‑functional teams, vendors, and network partners.

Qualifications

• On-site role; remote work is not permitted.
• Experience creating full validation lifecycle documentation (URS, FRS, DS, engineering specifications)
• 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 IQ/OQ/PQ/RQP execution plans
• Working knowledge of Computerized Systems Validation (CSV)
• Support implementation of new process technologies aligned with regulatory needs
• Vendor validation activities oversight and deviation reporting
• Willingness to work holidays and weekends

Responsibilities

• Provide scientific and technical support for product launches and technology transfers
• Execute key validation lifecycle activities (CD, CQ, PQ, PR)
• Collaborate with cross‑functional teams and network partners
• Develop and maintain validation documentation (protocols, reports)
• Ensure right‑first‑time execution, compliance and continuous improvement
• Mentor and guide junior team members
• Assist in implementing new process technologies
• Review and approve vendor protocols and deviation reports
• Coordinate sample collection and data retrieval per protocol requirements
• Prepare summary reports for validation activities

Skills

Cross-functional leadership

Project planning

Troubleshooting

Documentation writing

Regulatory understanding

Independent work

Mentoring juniors

Education

Bachelor’s degree in Engineering or Science

Tools

Kneat

MS Word

MS Excel

MS PowerPoint

Job description

BioPharma Consulting JAD Group is seeking a Validation Engineer to provide scientific and technical support for product launches, technology transfers, and new technologies at the FDBT site. The role emphasizes right‑first‑time execution, compliance, and continuous improvement.

You will execute key validation lifecycle activities (CD, CQ, PQ, PR) and collaborate with cross‑functional teams, vendors, and network partners.