External Partner Process Engineer

2 weeks ago


Dundalk, Maryland, United States Asset Recruitment Full time
Reference: 01158

Position: Process Engineer – Fill Finish

Overview:
The Technical Operations team within External Manufacturing (ExM) is seeking a driven individual for a role focused on Technical Transfer in Fill Finish operations. This team is responsible for overseeing technology transfers and the commercial production of sterile drug products at our External Partners (EPs).

Opportunity:
This role offers a chance for a proactive individual to engage in various aspects of the process, including:
  • Providing support for manufacturing processes to address potential production challenges.
  • Assisting in the execution of technology transfers.
  • Contributing to process and capacity optimization efforts.

Key Responsibilities:
  • Oversee technical activities related to commercial manufacturing processes at External Partners, including the creation of change control documentation, management of process improvement initiatives, statistical analysis of performance metrics, and investigation of unusual occurrences.
  • Manage technical transfer activities, ensuring compliance through the creation and review of necessary GMP documentation (e.g., Master Batch Records, change controls, protocols, reports, qualifications).
  • Provide on-site support at External Partners during Commercial and Technology Transfer activities.
  • Interpret GMP requirements and current regulations, developing standardized procedures in collaboration with Operations, Quality, and External Partners.
  • Ensure External Partners are prepared for all routine inspections and any inspections related to new product introductions or transfers, in coordination with Operations, Quality, and Regulatory teams.
  • Participate in the development and dissemination of best practices and business process strategies.

Travel Requirement:
Approximately 25% travel is expected.

Qualifications:
  • Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry, Biology, or a related field.

Experience and Skills:
  • Experience in tech transfer for fill finish products.
  • Minimum of 4 years of post-bachelor's experience in a GMP-related field, such as Operations, Technical Operations, Technology, Engineering, or Maintenance.

Preferred Experience and Skills:
  • Experience in Fill Finish activities, including Vial/Syringe finishing, sterilization, and aseptic manufacturing.
  • Familiarity with deviation management, change control, equipment support, and project management.
  • Ability to independently manage projects and adhere to deadlines.
  • Statistical analysis experience, including Proactive Process Analysis and Continuous Process Verification.


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