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Commissioning and Qualification Engineer
Reference: | SMC37495 | Location: |
Cork |
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
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
• Provide Technical Support for the commissioning and qualification of laboratory equipment including equipment IOQ and PQ
• Work with site support groups to deliver qualified raw materials and consumables for the manufacturing process.
• Author, review and approve manufacturing documentation associated with transferred processes.
• Troubleshoot technical issues and lead investigations through scientific problem-solving approaches.
• Partner with quality groups to support change management to implement process improvements
• Generate study plans, protocols and summary reports
• Establish and lead implementation the continued process verification program to effectively manage product life cycles.
• Adherence to highest standards for Compliance (Quality and Safety)
• Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, regulatory inspections and incident investigations.
Education & Experience
• Experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience
• BSc Degree in Biochemistry, Microbiology, Chemistry, Engineering or a related field
• 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.
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.
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