Cleaning Validation Technical Specialist

Team Horizon is seeking a Cleaning Validation Technical Specialist for a leading pharmaceutical company in Dublin.

Why you should apply:

• 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.

What you will be doing:

• 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.

What you need to apply:

• 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.