Process Engineer Tech Transfer
Purpose
This Technical Engineering role will play a key part in the development of the drug product facility. This role is to lead activities to deliver on the Tech Transfer requirements needed to support New Product Introduction.
Responsibilities
* Compliance: Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
* Process Engineering & Validation: To lead and execute process engineering and validation activities to support the technical transfers
* Projects: To lead and manage multiple Technical Engineering projects needed to support the business.
* Continuous Improvement: To manage and deliver on all technical/Validation/Quality Notifications/Change control/Project support within the technical engineering team.
Technical Expertise
* Act as a subject matter expert on equipment design, assisting in C&Q execution and planning; process design and validation.
* Liaise with global engineering services and facilities as well as specialist vendors on process requirements to deliver projects.
Qualifications
* A bachelor's degree or higher preferred; ideally in Science, Engineering or other Technical discipline.
* Minimum 4 years experience ideally in manufacturing, preferably GMP setting.
* Green Belt preferable Process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers/scientists through sustaining operations and technical transfer projects.