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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Cleaning Validation Engineer


Reference:AMC21688 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Validation Engineer

AMC21688
Cleaning Validation Engineer
Biotechnology - Cork
11 month contract

An excellent opportunity has arisen for a Cleaning Validation Engineer working on a Vaccines IPT in a global biopharmaceutical manufacturer in Cork.

In this role you will provide cleaning cycle development and cleaning validation and technical support to the Vaccines IPT team.

What skills you will need:

  • 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 relevant degree
  • 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

The role
  • Develop and validate cleaning cycles, including the Performance Qualification (PQ) of equipment.
  • Create and follow validation strategies, coordinate with external vendors, write protocols independently, submit samples, analyze test results, and prepare technical reports.
  • Conduct routine business activities, such as periodic equipment reviews, cleaning reviews, Corrective and Preventive Actions (CAPAs) and deviations, change control, and risk assessments.
  • Support the commissioning phase by reviewing and approving documents, ensuring compliance with standards.
  • Participate in cross-functional problem-solving teams for troubleshooting and investigations within the Vaccines Integrated Process Team (IPT).
  • Write technical reports and perform statistical data analysis.
  • Adhere to the latest regulatory guidelines.
  • Represent the IPT on cross-functional project teams.
  • Provide technical input and support, and act as a Subject Matter Expert (SME) during regulatory inspections.
  • Maintain the highest standards for compliance in quality and safety.
  • Ensure compliance with site Environmental Health and Safety (EHS) policies, current Good Manufacturing Practices (cGMP), and other regulations. Support Technical IPT in risk assessments, audits, regulatory inspections, and incident investigations.
  • Uphold the highest Quality, Compliance, and Safety standards by adhering to our Manufacturing Division Quality Management System (QMS) requirements, including relevant ownership responsibilities.

If you are interested in this posting please apply today or feel free to contact Angela McCauley on +353 (0)87 693 0951 or [email protected] for further information.