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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Technical Transfer Engineer - Fill Finish


Reference:SMC34795 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Process Engineer

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

  • 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.
  • Work with External Partners to achieve business goals and to establish a common culture that benefits our company, External Partners, and patients.

Education & 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 fill finish product tech transfer experience for this role
  • Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
  • 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.
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.