LSC have a great contract opportunity for a Commissioning & Qualification Engineer to join a global Biopharmaceutical company in Cork. The facility specializes in the fermentation, purification, and sterile filling of biotech products, as well as supporting product development and clinical trials.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- 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
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 3+ years' experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience
- 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.
- BSc Degree in Biochemistry, Microbiology, Chemistry, Engineering or a related field
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Sarah Ninan at +353 21 4777329 if you have any more questions about this opportunity!
