Senior Technical Transfer Specialist

2 weeks ago

Brinny, Cork, Ireland beBee Careers Full time

As a Technical Transfer Engineer, you will play a key role in ensuring the smooth transition of commercial manufacturing processes at External Partners. This involves working closely with these partners to achieve business goals and fostering a collaborative culture that benefits all parties.

Key Responsibilities:

  • Authorship of change control documents, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events
  • Technical transfer activities through authorship and/or review of GMP documentation and regulatory filings
  • Providing on-site support at External Partner sites for Commercial and/or Technology Transfer Person-In-Plant Activities
  • E nsuring External Partners are inspection ready for routine inspections and new product introductions or transfers
  • Developing standardized work to meet GMP requirements and current regulations by partnering with Operations, Quality, and External Partners
  • Participating in the creation, sharing, and adoption of business process and best practices strategies

Requirements:

  • Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology
  • 4 years+ post-bachelor's degree experience in a GMP functional area or support of a GMP functional area
  • Great communication skills in English and teamwork skills
  • Travel requirement of approximately 25%

Desirable Qualifications:

  • Experience in deviation management and/or change control and/or equipment support, and/or project management
  • Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development, and tech transfer
  • Statistics experience (including Proactive Process Analysis and Continuous Process Verification)
  • Able to independently manage projects/work to schedule/deadlines

This position offers an exciting opportunity for a results-driven individual to make a significant impact in a dynamic environment. As a home-based role located anywhere in Europe, you will have the flexibility to work independently while collaborating with a global team. If you are passionate about technical transfer and have a strong background in GMP functional areas, we encourage you to apply for this challenging and rewarding position.

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