Job Overview
The Process Engineering and Cleaning Validation Lead plays a crucial role in managing cleaning validation activities for the cGMP manufacture of biological bulk drug substance at our facility.
This position involves providing expertise to support facility start-up and routine commercial manufacturing through effective management of cleaning validation specialists and contractors.
* Lead a team of cleaning validation specialists and oversee associated budgets, ensuring seamless execution of cleaning validation activities.
* Develop and implement PEV procedures and plans for cleaning validation activities.
The ideal candidate will possess:
* A minimum of 8 years' experience in cleaning validation, including 3 years' leadership experience.
* Extensive experience in cleaning validation for drug substance and/or drug product processing equipment in a multiproduct facility.
* Proven program management capabilities with strong interpersonal skills.
Key competencies include attention to detail, troubleshooting, and effective communication skills.