Validation Officer - Continued Process Verification (m/w/d), API Manufacturing
Core
Lead validation teams to develop and implement process validation and Continued Process Verification (CPV) strategies for various products and manufacturing processes, ensuring long-term process performance through statistical analysis.
Role type
Process Validation and CPV Lead (Chemical/Pharmaceutical Manufacturing)
Builds
Validated manufacturing processes and continuous verification strategies for chemical and biotechnological products
Domain
Life Sciences / Chemical Manufacturing / GMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation strategy development, Continued Process Verification (CPV) strategy formulation, statistical process analysis, GMP compliance planning, cross-functional collaboration, structured planning and documentation
Preferred skills
Knowledge of quality standards and regulatory requirements for process validation, statistical methods expertise, GMP experience
Technologies
GMP, statistical analysis tools, process monitoring systems
Responsibilities
Develop product process validation strategies to ensure reproducible production, accompany project teams through the entire validation cycle, formulate CPV strategies to maintain validated procedures using statistically evaluated parameters, plan GMP-compliant improvements and changes, ensure compliance regarding process validation
Seniority
Mid-Senior, hands-on IC