Senior Process Validation & Tech Transfer Lead

United Pharma; Missouri; On-site; USD 90,000 - 130,000; Full time

Job summary

United Pharma is seeking a Product Process Validation Manager to lead validation strategy across the product lifecycle. The role collaborates with Process Development, Quality, Manufacturing, and Regulatory Affairs to ensure compliant validation programs.

The ideal candidate will drive PPQ protocols, CPV, and technology transfer, guiding cross-functional teams and mentoring MS&T staff. Excellent technical writing and regulatory knowledge are essential.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, or related field.
• 7+ years of experience in biopharmaceutical or pharmaceutical manufacturing, MS&T, process validation, or related technical function.
• Demonstrated expertise in PPQ, CPV, and technology transfer
• Strong understanding of cGMP regulations and global validation guidelines
• Excellent technical writing, communication, and project management skills

Responsibilities

• Lead development, authorship, and execution of process validation strategies aligned with regulatory expectations (FDA, EMA, ICH Q8–Q11).
• Write, review, and approve PPQ protocols, sampling plans, risk assessments, and final reports.
• Coordinate cross-functional PPQ readiness with Manufacturing, Quality Control, and QA.
• Ensure validation deliverables meet internal standards and regulatory requirements.
• Lead technology transfer of new products or scale-ups into manufacturing and maintain transfer docs.
• Drive risk analyses, fit-gap assessments, and mitigation plans.
• Support equipment readiness, URS development, and CPV activities.
• Monitor process performance with analytics teams and lead investigations for deviations.
• Provide technical leadership during audits and regulatory inspections.

Skills

Process validation

PPQ

CPV

Technology transfer

Regulatory compliance

Technical writing

Project management

Education

Bachelor’s or Master’s degree in Engineering/Life Sciences/Biotechnology

Tools

JMP

Minitab

Job description

United Pharma is seeking a Product Process Validation Manager to lead validation strategy across the product lifecycle. The role collaborates with Process Development, Quality, Manufacturing, and Regulatory Affairs to ensure compliant validation programs.

The ideal candidate will drive PPQ protocols, CPV, and technology transfer, guiding cross-functional teams and mentoring MS&T staff. Excellent technical writing and regulatory knowledge are essential.