Cleaning Validation Engineer

PE Global is currently recruiting for a Cleaning Validation Engineer for a leading multi-national BioPharma client based in Cork.

This is an initial 12 month contract position.

The primary responsibility will be Cleaning Validation. Other activities may include Process Validation Support (e.g. Mixing Studies, Media Challenge), Thermal Validation, Process Validation, Change Control, Exception/Event Investigations/Closure.

Duties of the role/Responsibilities

• Conduct MSAT activities in compliance with US and EU regulations, JSI procedures and EHS&S requirements.
  • Develop MSAT documentation as required (e.g. strategies, plans, protocols, procedures, reports).
  • Review and approve documents prepared by the MSAT.
  • Execute MSAT protocols as required.
  • Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
  • Prepare reports for executed protocols for review and approval.
  • Initiate and implement change control activities in accordance with site procedures.
  • Track and resolve exceptions/events/deviations during MSAT activities.
  • Prioritize MSAT activities in line with the project schedule.
  • Co-ordinate MSAT activities with engineering, construction and commissioning activities.
  • Co-ordinate MSAT activities with contractors and vendors as required.
  • Co-ordinate MSAT document review and approval.
  • Collate and organize MSAT files for turnover to QADC.
  • Attend identified training, required to fulfill the role of a MSAT Specialist.
  • Assist in the development of training material for MSAT activities.
  • Participate in cross-functional teams as required.
  • Deputise for the MSAT Manager or other team member where required.
  • Domestic and international travel may be required.

Education/Experience

• To Bachelor’s Degree in a scientific/technical discipline required
• 5+ Years Cleaning Validation Experience.
• Experience in a large molecule facility.
• Experience in other Validation areas (e.g.Process Validation Support (e.g. Mixing Studies, Media Challenge), Thermal Validation, Process Validation).
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply cGMP regulations and guidelines to all aspects of MSAT activities.
• Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Chloe on +353 21 4297900 or alternatively send an up to date CV to chloe.slingsby@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***