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Manufacturing Process Specialist

2 weeks ago

Sligo, Sligo, Ireland TEAM HORIZON Full time
Company Overview:

Team Horizon is a world-class manufacturing operation with an outstanding track record of delivering high-quality medicines globally. Our company culture emphasizes continuous improvement and innovation, striving for solutions that enhance health outcomes and improve lives.

About the Role:

The Manufacturing Process Specialist will serve as a Subject Matter Expert (SME) in formulation, aseptic filling processes, and isolator technology. This role represents the team at regulatory audits, owns manufacturing equipment and process knowledge, sources process equipment with technical oversight, and provides technical support for manufacturing processes and equipment. The successful candidate will also collaborate with technical experts across the network to ensure consistency and best practices, design and implement technical studies, and drive process improvements for enhanced performance and cost reduction.

Key Responsibilities:
  • Serve as a Subject Matter Expert (SME) in formulation, aseptic filling processes, and isolator technology.
  • Represent the team at regulatory audits.
  • Own manufacturing equipment, process knowledge, and technology.
  • Source and procure process equipment with technical oversight.
  • Provide technical support for manufacturing processes and equipment.
  • Collaborate with technical experts across the network to ensure consistency and best practices.

Requirements:
  • Minimum level 8 qualification in an engineering, science, or technical discipline.
  • At least three years in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale-up, commissioning, and validation in a cGMP pharmaceutical or Biologics industry.
  • Strong record of achievement.
  • Demonstrated experience of technical writing of complex issues.
  • Must have experience in taking a lead role in investigations.
  • Good knowledge of quality systems both FDA and EU regulations as they relate to manufacturing, facilities, and process engineering.