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Senior Process Engineer

Job description

An exciting opportunity awaits with a global pharmaceutical company based in Cork for a Senior Process Engineer on a contract basis.

Job responsibilities: 

  • Providing Technical Support for the commissioning and qualification of the drug substance manufacturing process including equipment IOQ and PQ
  • Supporting the facility start-up process by leading/participating in work groups to realise successful facility qualification and validation
  • Working with site support groups to deliver qualified raw materials and consumables for the manufacturing process.
  • Supporting the technology transfer of drug substance manufacturing process through effective collaboration with business partners and customers.
  • Author, review and approve manufacturing documentation associated with transferred processes.
  • Troubleshooting manufacturing issues and leading investigations through scientific problem-solving approaches.
  • Partnering with quality groups to support change management for the manufacturing process.
  • Generating study plans, protocols and summary reports to support the manufacturing process.
  • Leading and participating in process validation studies including but not limited to, cleaning studies, mixing studies and process characterisation studies.
  • Establishing and leading implementation the continued process verification program to effectively manage product life cycles.
  • Actively participating in a culture of Continuous Improvement and process optimisation by deploying Lean Six Sigma tools.

 

Job requirements:

  • 6+ years’ experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience
  • BSc Degree qualified
  • Experience in at least two of the following areas: protein chemistry, process engineering, cell culture, purification technologies, process operations, statistics, technology transfer, microbiological control of bio-manufacturing processes, cleaning validation, process validation, regulatory inspections.
  • Evidence of Continuous Professional Development and cross skilling
  • Six Sigma experience

This is an initial 11 months contract. (No shift work required)

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel@sigmar.ie

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