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 of 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 ****** for further information.
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