Manager, Process Validation & Verification

Thermo Fisher Scientific • St. Louis, MO

2d • Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. How you will make an impact: The Manager, Process Validation & Verification provides site-level technical and organizational leadership for process validation (PPQ) and continued process verification (CPV) activities supporting clinical and commercial biologics manufacturing at the St. Louis, MO facility. This role serves as the site owner for validation lifecycle execution and governance, ensuring processes are qualified, monitored, and maintained in a state of control in alignment with regulatory requirements and company standards. The Manager partners cross-functionally with MSAT, Manufacturing, Quality, Regulatory, Supply Chain, and Project Management to ensure compliant and efficient lifecycle execution. What you will do: Site Validation Governance & Execution Lead and maintain the site strategy for process validation and continued process verification Establish governance routines for PPQ and CPV monitoring and reporting Ensure lifecycle alignment from process design through validation and ongoing verification Define and track validation KPIs and process capability metrics Drive continuous improvement in validation and verification practices Process Validation & PPQ Oversight Provide technical oversight for PPQ strategy and execution across clinical and commercial programs Ensure validation approaches are science- and risk- based and aligned with regulatory expectations Review and approve validation protocols, reports, and lifecycle documentation Serve as site technical escalation point for complex validation issues Ensure validation documentation supports regulatory submissions and inspection readiness Continued Process Verification (CPV) Ownership Own execution of the site CPV program, including statistical trending and signal detection Establish and maintain escalation criteria for process performance signals Lead routine CPV reviews with site stakeholders Partner with MSAT and Quality to address process capability concerns Ensure CPV outputs support manufacturing and quality decision-making Cross- Functional & Client Partnership Partner with MSAT, Process Engineering, Manufacturing Operations, Quality, Regulatory Affairs, Supply Chain, and Project Management Represent validation in site governance forums Support client discussions related to validation and lifecycle performance Contribute to alignment with division and global validation standards People Leadership Lead and develop validation engineers/scientists Establish clear expectations, accountability, and performance standards Provide coaching, mentoring, and performance management Support hiring and onboarding efforts Foster a culture of compliance, technical rigor, and ownership Compliance & Inspection Readiness Ensure inspection readiness for validation and CPV programs Support regulatory inspections and client audits Partner with Quality to ensure timely closure of validation- related CAPAs Maintain dashboards and reporting tools for site leadership

Requirements

• Bachelor's degree in Engineering, Biotechnology, Biochemistry, Chemistry, Pharmaceutical Sciences, or related scientific discipline required
• Master's degree preferred
• Equivalent combination of education and experience may be considered
• 8+ years of experience in biopharmaceutical manufacturing, MSAT, process engineering, validation, or related technical function
• Minimum 2+ years of formal or informal people leadership experience
• Experience supporting Process Performance Qualification (PPQ) and/or Continued Process Verification (CPV) activities
• Experience authoring and reviewing validation protocols and lifecycle documentation
• Working knowledge of FDA, EMA, and ICH guidance related to process validation
• Experience supporting regulatory inspections and/or client audits
• Experience working within cross-functional, matrixed organizations
• Strong understanding of process validation regulations (FDA, EMA, ICH Q8/Q9/Q10)
• Ability to interpret data and make risk- based decisions
• Strong written and verbal communication skills
• Ability to influence cross- functional stakeholders
• Data- driven and continuous improvement mindset
• Ability to manage complexity and regulatory risk
• Ability to work in manufacturing environments, including gowning and PPE
• Ability to sit and work at a computer for extended periods
• Occasional off- shift support may be required
• Must be legally authorized to work in the United States now and in the future, without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

• Experience supporting commercial biologics manufacturing
• Strong statistical knowledge (control charts, process capability analysis)
• Experience leading validation governance reviews
• Lean/Six Sigma certification

Responsibilities

• Site Validation Governance & Execution Lead and maintain the site strategy for process validation and continued process verification
• Establish governance routines for PPQ and CPV monitoring and reporting
• Ensure lifecycle alignment from process design through validation and ongoing verification
• Define and track validation KPIs and process capability metrics
• Drive continuous improvement in validation and verification practices
• Process Validation & PPQ Oversight Provide technical oversight for PPQ strategy and execution across clinical and commercial programs
• Ensure validation approaches are science- and risk- based and aligned with regulatory expectations
• Review and approve validation protocols, reports, and lifecycle documentation
• Serve as site technical escalation point for complex validation issues
• Ensure validation documentation supports regulatory submissions and inspection readiness
• Continued Process Verification (CPV) Ownership Own execution of the site CPV program, including statistical trending and signal detection
• Establish and maintain escalation criteria for process performance signals
• Lead routine CPV reviews with site stakeholders
• Partner with MSAT and Quality to address process capability concerns
• Ensure CPV outputs support manufacturing and quality decision-making
• Cross- Functional & Client Partnership Partner with MSAT, Process Engineering, Manufacturing Operations, Quality, Regulatory Affairs, Supply Chain, and Project Management
• Represent validation in site governance forums
• Support client discussions related to validation and lifecycle performance
• Contribute to alignment with division and global validation standards
• People Leadership Lead and develop validation engineers/scientists
• Establish clear expectations, accountability, and performance standards
• Provide coaching, mentoring, and performance management
• Support hiring and onboarding efforts
• Foster a culture of compliance, technical rigor, and ownership
• Compliance & Inspection Readiness Ensure inspection readiness for validation and CPV programs
• Support regulatory inspections and client audits
• Partner with Quality to ensure timely closure of validation- related CAPAs
• Maintain dashboards and reporting tools for site leadership

Benefits

• We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
• Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
• We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
• Relocation assistance may be provided.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees