Process Engineer role supporting introduction of new sterile injectable manufacturing processes at a pharmaceutical manufacturing facility. Responsible for technical documentation, process validation support, and regulatory compliance in line with GMP and FDA standards.
Responsibilities
- Issue and draft engineering and technical documentation for manufacturing process validation
- Participate in project teams to discuss technical aspects of new product introduction strategies
- Support operational execution of activities from technical perspective
- Review and analyze shopfloor-generated data according to protocols and procedures
Requirements
- Degree in Pharmacy, Chemistry, Biotechnology, Biology, or Engineering
- Proficient English, written and spoken
- Experience with pharmaceutical IT systems (PMX, LIMS, Trackwise, Minitab)
- Proficiency in Microsoft Office tools
- Strong interpersonal skills and ability to work collaboratively