Validation Specialist

  • Cork

Website TPM05424

Summary:
An amazing opportunity has arisen with our client, a global biopharmaceutical company with a facility in Cork. The successful candidate will provide validation (utilities PQ, equipment PQ, cleaning validation) and technical support.

Responsibilities:

  • Execute cycle development, cleaning validation 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 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 Vaccine manufacturing.
  • Technical report writing, statistical analysis of data.
  • Adherence to the latest regulatory guidelines.
  • Represent Operations on cross-functional project teams.
  • Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
  • Adherence to highest standards for Compliance (Quality and Safety).
  • Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical Operations input to risk assessments, audits, regulatory inspections and incident investigations.
  • Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

Qualifications & Experience:

  • 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 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.

To apply for this job email your details to orla.daly@tandempm.ie.