Cleaning Validation Consultant

Our client is a prominent API manufacturing facility based in Ireland. As the site expands with a new building and prepares for a significant increase in production capacity, they are seeking a high-level specialist to spearhead their cleaning validation strategy. This is a critical time for the site as they transition into a more robust, formal policy framework for their manufacturing processes.

Reporting directly to the Validation Manager, you will act as the technical lead and subject matter expert for cleaning validation on-site.

• Strategic Development: Consult for cleaning validation on-site, developing and implementing a site-wide policy from the ground up.
• Execution: Lead and carry out various cleaning studies to ensure API processes are compliant, efficient, and "neat."
• Compliance: Ensure all strategies meet the rigorous standards of HPRA and FDA regulations.
• Consultancy: Provide expert-level guidance to ensure the new building's cleaning validation is integrated seamlessly into site operations.

Experience

We are seeking a seasoned expert who can slot straight in and provide immediate consultancy-level value.

• Experience: 10+ years experience in Cleaning Validation.
• Expertise: Deep knowledge of HPRA/FDA audit requirements and a proven track record of successful audit outcomes.
• Skills: Ability to work autonomously to establish formal policies and provide high-level guidance to the wider validation team. xcfaprz
• Flexibility: Part-time schedule (2 days per week) with hybrid/remote working options available.