Validation Engineer

Life Science Consultants

  • Cork
  • Permanent
  • Full-time
  • 26 days ago
LSC have a great contract opportunity for a Validation 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:
  • Execute cleaning cycle development and PQ of equipment.
  • Writing and adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
  • Execute run the business activities e.g., equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
  • Provide support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards.
  • Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
  • Technical report writing, statistical analysis of data
ABOUT YOU - ARE YOUR SKILLS A MATCH?
  • 3-5 years' experience as a validation specialist in a pharmaceutical or a highly regulated environment and a B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field.
  • Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
  • A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS and eVAL, electronic batch records.
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!

Life Science Consultants

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