An exciting opportunity awaits with a global pharmaceutical company based in Cork for a Senior Process Engineer on a contract basis.
- 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.
- 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
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / email@example.com
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