Product Process Validation Manager

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

The is an exciting opportunity as Product Process Validation Manager is a key member of the Manufacturing Science & Technology (MS&T) organization, responsible for leading process validation strategy and execution across the product lifecycle. This role oversees the design, authorship, and facilitation of technology transfer activities, Process Performance Qualification (PPQ) protocols and reports, and supporting ongoing Continued Process Verification (CPV). The manager partners closely with Process Development, Quality, Manufacturing, and Regulatory Affairs to ensure robust, compliant, and efficient validation programs. This position reports directly to the Director of MS&T.

Role Responsibilitie

Process Validation & PP

• QLead the development, authorship, and execution of process validation strategies in alignment with regulatory expectations (e.g., FDA, EMA, ICH Q8–Q11)
• Write, review, and approve PPQ protocols, sampling plans, risk assessments, and final reports
• Facilitate cross-functional PPQ readiness, including coordinating activities with Manufacturing, Quality Control, and Quality Assurance
• Ensure validation deliverables meet internal standards and external regulatory requirements
• Serve as the MS&T lead for technology transfer of new products, processes, or scale-up activities into manufacturing
• Develop and maintain tech transfer plans, process descriptions, and knowledge transfer documentation
• Drive process fit-gap assessments, risk analyses, and mitigation strategies
• Support equipment and facility readiness, including URS development and process capability assessments

Continued Process Verification (CPV

• Partner with data analytics and quality teams to monitor process performance, identify trends, and drive data-based decision-making
• Lead investigations and corrective actions related to process performance deviations or CPV signals

Cross-Functional Leadershi

• Collaborate with Process Development to translate laboratory-scale processes into robust, scalable manufacturing processes
• Support Regulatory Affairs with process validation content for submissions, responses to regulatory queries, and inspections
• Provide technical leadership during audits and regulatory inspections
• Mentor and guide junior MS&T staff in validation and tech transfer best practices

Documentation & Complianc

• Ensure all validation and tech transfer documentation is accurate, complete, and audit-ready
• Maintain strong alignment with internal quality systems, change control, and document management processes
• Champion continuous improvement initiatives to enhance validation efficiency and process robustness

Basic Qualificatio

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

Preferr

• Experience with biologics, cell therapy, gene therapy, or aseptic manufacturin
• Familiarity with statistical tools (e.g., JMP, Minitab) for process analysi
• Prior leadership or team management experienc
• Experience supporting regulatory inspection