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
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