Cleaning Validation Specialist

  • Contract
  • Cork

Website TPM05526

Summary:
Our client is a biopharmaceutical company based in Cork looking for a Senior Cleaning Validation Specialist to provide validation, primarily cleaning cycle development and cleaning validation and technical support to their vaccines team.

Responsibilities:

  • Execute cleaning 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 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.
  • Technical report writing, statistical analysis of data.
  • Adherence to the latest regulatory guidelines.
  • 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 input to risk assessments, audits, regulatory inspections and incident investigations.
  • Ensure the highest Quality, Compliance and Safety standards by participating and complying with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

Qualifications & Experience:

  • B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or a related field.
  • 3-5 years’ experience as a validation specialist in a pharmaceutical or a highly regulated environment.
  • 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.

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