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 sean.mccarthy@lifescience.ie for further information.
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