Role overview
Validation and quality engineering professional who rebuilds the cleaning validation program and supports facility, equipment and engineering remediation. Candidates must meet the minimum experience for both cleaning validation and validation / quality engineering.
Key responsibilities
- Run a gap assessment of the cleaning validation program; define cleanability, worst-case matrix, limits (e.g. HBEL/PDE-based) and swab locations
- Write cleaning validation protocols, support execution and write reports; set up periodic review
- Assess facility and equipment condition; prioritize maintenance work orders by quality risk
- Define clean-down and release evidence and room/equipment readiness criteria
- Integrate corporate engineering remediation actions; support process qualification and change management
- Review qualification protocols and reports for technical and GMP adequacy
Mandatory requirements
- 5+ years in cleaning validation strategy and execution in pharmaceutical manufacturing
- 5+ years in validation or quality engineering, including protocol and report review
- Knowledge of equipment qualification (IQ/OQ/PQ), change control and risk management (ICH Q9)
- Experience with cross-contamination control in multi-product facilities
Plus the common requirements listed on page 1.
Preferred qualifications
- Solid oral dosage multi-product facility experience
- Experience with HBEL/PDE toxicological limit setting
- Engineering degree (chemical, mechanical or similar)
Experience supporting facility remediation after quality events (e.g. foreign matter)
