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Process Engineer – Fill Finish
The External Manufacturing (ExM) Technical Operation organization is looking for a results-driven candidate for a Technical Transfer – Fill Finish position. ExM Technical Operation is accountable for technology transfers and commercial production of sterile drug product at our External Partners (EPs).
This is an opportunity for a motivated person to participate in all these areas, including providing manufacturing process support to solve potential commercial production issues, supporting execution of technology transfers and to provide support for process and capacity optimization.
• Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
• Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
• Provide on-site coverage at External Partner in support of Commercial and / or Technology Transfer Person-In-Plant Activities.
• Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners.
• Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.
• Responsible for participation in creating, sharing, and adopting best practices and business process strategies.
• Travel will be a requirement at approximately 25%
• Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
Experience and Skills:
• Fill finish product tech transfer experience
• 4 years+ post-bachelor’s degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance
Preferred Experience and Skills:
• Experience in Fill Finish activities – Vial / Syringe finish, Sterilization, cleaning aseptic manufacturing, etc.
• Experience in deviation management and/or change control and/or equipment support, and/or project management.
• Ability to independently Manage projects/work to schedule/deadlines
• Statistics experience (including Proactive Process Analysis and Continuous Process Verification)