Cleaning Validation Technical Specialist

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
• You enjoy working on exciting projects and want to work with a global manufacturing site in Dublin.

• This role requires close collaboration with various departments and offers the opportunity to lead cleaning programs for Upstream and Downstream equipment.
• 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.
• Good interpersonal skills coupled with proven ability to work effectively in a matrix organisation and in local group.
• Ability to drive for results independently and adapt to rapidly evolving priorities.
• Experience in cleaning validation and cleaning approaches to a multiproduct facility is advantageous.
• Detail orientated and be proficient at technical writing.
• 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.
• Ability to manage competing priorities to ensure timely delivery of tasks.
• Any other duties as assigned.

• 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.

Team Horizon