Senior Technical Transfer Specialist

15 hours ago


Carlow, Ireland beBeeCompliance Full time €90,000 - €105,000
Technical Transfer Leader We are seeking a highly skilled Technical Transfer Leader to join our organization. The successful candidate will be responsible for leading and executing process engineering and validation activities to support technical transfers, as well as managing multiple Technical Engineering projects to support the business. Key Responsibilities:  • Ensure compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections, and proactively highlight any issues around compliance.  • Lead and execute process engineering and validation activities to support technical transfers.  • Manage and deliver on all technical/Validation/Quality Notifications/Change control/Project support within the technical engineering team.  • Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g., Structured Root Cause Analysis, Statistical Process Control, Data-driven decision making).  • Drive collaboration between group functions and proactively look for synergies and innovative ways of doing work. Constantly assess our systems and processes to see what improvement we can make to work smarter and more efficiently while being compliant.  • Act as a subject matter expert on Equipment Design, assisting in C&Q execution and planning, Process design and validation.  • Act as a liaison with global engineering services and facilities as well as specialist vendors on process requirements to deliver projects. Requirements: The ideal candidate will have: • Considerable experience in a comparable role, typically operating as a senior professional and adding considerable value to the business. • Process engineering and/or validation experience in a sterile manufacturing environment, with a proven track record in leading a technical team of engineers/scientists through sustaining operations and technical transfer projects. • In-depth knowledge and experience of Sterile filling processes and equipment, especially aseptic processing. • Experience of executing and/or managing through equipment and process validation in a sterile environment. • Good shipping/Filter/Cleaning validation knowledge required. • Automation and MES knowledge. • Proven record of process improvement implementation. • Proven record in planning and basic project management of a team to deliver on time/schedule and cost. 


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