Technical Transfer Engineer (Fill Finish)

Summary:
Our client is a biopharmaceutical company based in Cork looking for a Tech Transfer Engineer to take responsibility for technology transfers and commercial production of sterile drug product at external partners. This will include supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and to provide support for process and capacity optimization.

Responsibilities:

• Work with external partners to deliver technical transfer of our vaccine and biologics programs.
• 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.

Qualifications & Experience:

• Minimum of 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.
• Must have 3-5 years fill finish technical transfer experience for this role.
• Travel will be a requirement of this position at approximately 25-40%.
• Experience in fill finish activities – (vial / syringe finish, sterilization, cleaning aseptic manufacturing, etc.).
• Statistics experience (including proactive process analysis and continuous process verification).
• Experience in deviation management and/or change control and/or equipment support, and/or project management.