Production Technician

23 hours ago

Dublin, Dublin City, Ireland beBeeTransfer Full time €60,000 - €80,000
Job Description

A pharmaceutical company is seeking a Technical Transfer Specialist to provide process development support for new product introductions and lifecycle management changes.

The successful candidate will be responsible for providing solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products through the NPI or post-NPI phases.

Key Responsibilities
  • Provide technical expertise for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer and validation.
  • Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer.
  • Development of validation plans, process performance qualifications for vial and syringe filling.
  • Ensure that the site meets quality requirements of its customers and applicable regulations.

Required Skills:

  • 3+ years of experience in Commercial Protein Drug Product (DP) processing.
  • Strong skills in applying fundamental engineering and scientific principles.
  • Knowledge of protein biochemistry regarding chemical and physical stability.
  • Project management skills including ability to manage multiple projects.
  • Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.

Benefits:

  • 35% shift rate applies.
  • Confirmed shift pattern: 2 days on 7am-7pm, 2 nights on 7pm-7am, 4 days off.

Requirements:

  • Valid working VISA in Ireland or European Passport.

How to Apply:

Candidates must have strong communication skills and be able to lead cross-functional teams to advance complex projects.

Technical Evaluation Expertise:

  • Process development support for commercial drug product processing.
  • Technical evaluation of Change Control/NC/CAPA and technology transfer.
  • Validation plans, process performance qualifications for vial and syringe filling.

Leadership Skills:

  • Ability to manage multiple projects.
  • Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.

Regulatory Compliance:

  • Ensuring site meets quality requirements of its customers and applicable regulations.

Site Requirements:

  • Meet quality requirements of its customers and applicable regulations.

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