Technical Operations Engineer

2 weeks ago

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

Position: Process Engineer – Fill Finish


Asset Recruitment is seeking a dedicated and results-oriented individual for a role in Technical Transfer – Fill Finish.

The Technical Operations team is responsible for overseeing technology transfers and the commercial production of sterile drug products at our External Partners.


This position offers a chance for an enthusiastic candidate to engage in various aspects of the role, including providing support for manufacturing processes to address potential production challenges, facilitating technology transfers, and contributing to process and capacity enhancements.


Key Responsibilities:

  • Oversee technical activities related to the commercial manufacturing process at External Partners, which includes drafting change control documents, managing process improvement initiatives, conducting statistical analyses of process performance, and investigating unusual events.
  • Manage technical transfer activities as needed, including the creation and/or review of essential GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory submissions.
  • Provide on-site support at External Partners for Commercial and/or Technology Transfer Person-In-Plant Activities.
  • Interpret GMP requirements and current regulations, developing standardized procedures to comply with these standards in collaboration with Operations, Quality, and External Partners.
  • Ensure that External Partners are prepared for all routine inspections and inspections related to new product introductions or transfers, in coordination with Operations, Quality, and Regulatory teams.
  • Participate in the development, sharing, and implementation of best practices and business process strategies.

Travel Requirement:

  • Travel is expected to be approximately 25%.

Qualifications:

  • A Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry, Biology, or a related scientific or engineering discipline.

Experience and Skills:

  • Experience in fill finish product technology transfer.
  • A minimum of 4 years of post-bachelor's degree experience in a GMP functional area or supporting a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, or Maintenance.

Preferred Experience and Skills:

  • Familiarity with Fill Finish activities, including Vial/Syringe finishing, sterilization, and aseptic manufacturing cleaning.
  • Experience in deviation management, change control, equipment support, or project management.
  • Proven ability to independently manage projects and adhere to schedules and deadlines.
  • Proficiency in statistics, including Proactive Process Analysis and Continuous Process Verification.

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