Commissioning and Qualification Engineer

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 sean.mccarthy@lifescience.ie for further information.