Cleaning Validation Specialist

3 weeks ago

Dublin, Dublin City, Ireland Tandem Project Management Ltd. Full time

Summary:

Our client is a biopharmaceutical company based in Dublin looking for a Cleaning Validation Technical Specialist you will play a key role in supporting the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at their facility in Dublin.

Responsibilities:

  • Prepare and review relevant cleaning validation documentation including but not limited to protocols, reports, plans, risk assessments, technical/impact assessments.
  • Provide input on cleaning processes and troubleshoot/support cleaning activities related to both commercial operations and new product introduction.
  • Provide support for the technical services team during regulatory agency inspections.
  • Identify operational process improvements using Lean Tools
  • Assist with the investigation of and operations deviations through the eQMS system, engaging with all relevant personnel and functions as appropriate.
  • Participating in technical projects, inclusive of process optimisation projects.
  • Responsibility for Change Management and Deviation Management.

Qualifications & Experience:

  • Degree qualification in science or engineering discipline.
  • Minimum of three years' experience in cleaning validation, preferably in bulk drug substance manufacturing.
  • Experience in lean processing is an advantage.
  • Experience in preparation of routine documentation to GMP standard Experience working with digital tools and applications (MS Office, Adobe etc) Ability to read, comprehend and prepare applicable documentation required
  • Technical and operational knowledge of cleaning validation/verification of upstream and downstream equipment, quality systems and regulatory requirements across multiple health authorities.
  • Knowledge of downstream purification processes such as ultrafiltration is desirable.
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
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