Competitive remuneration; annual incentive plan bo...
8+ years biopharmaceutical manufacturing experience
Process performance qualification (ppq) oversight
Continued process verification (cpv) ownership
The role provides site-level technical leadership for process validation and continued process verification activities supporting clinical and commercial biologics manufacturing
Job Summary
The role provides site-level technical leadership for process validation and continued process verification activities supporting clinical and commercial biologics manufacturing.
Candidates will partner cross-functionally with MSAT, Manufacturing, Quality, and Regulatory teams to ensure compliant lifecycle execution and inspection readiness.
Thermo Fisher Scientific offers competitive remuneration, an annual incentive plan bonus, healthcare, and outstanding career development prospects in a culture of integrity and innovation.
Matching Summary
The role provides site-level technical leadership for process validation and continued process verification activities supporting clinical and commercial biologics manufacturing.
Salary
Competitive remuneration; Annual incentive plan bonus available; Healthcare and employee benefits included
Skills & Requirements
Must-have
8+ years biopharmaceutical manufacturing experience
Process Performance Qualification (PPQ) oversight
Continued Process Verification (CPV) ownership
FDA, EMA, ICH regulatory guidance knowledge
Validation protocol authoring and review
Cross-functional stakeholder partnership
Nice-to-have
Lean/Six Sigma certification
Strong statistical analysis skills
Commercial biologics manufacturing background
Continuous improvement mindset
Data-driven decision making ability
Key Requirements
Bachelor's degree in Engineering or related scientific discipline
Minimum 2+ years people leadership experience
Must be legally authorized to work in the United States without sponsorship