Validation Engineer

  • Negotiable
  • Westport, Republic of Ireland

About Your New Employer

A pharmaceutical company are hiring for a Process Engineer to join their site in Westport on a permanent basis or on a 12-month fixed term contract. 3+ years relevant experience is required as well as a Level 8 degree.

About Your New Job   

As a Validation Engineer you will…

  • Over-see, coordinate, guide and implement the site validation master plan under prospective, concurrent and retrospective validation studies in a timely manner, with the relevant engineers
  • Ensure that all validation requirements are met for any new process, equipment or change to existing processes or equipment.
  • Actively work on validation projects, being the departmental point person, and completing all associated project documentation in line with current corporate and regulatory expectations
  • Ensure that all documentation pertaining to each validation study under his/her responsibility is compiled, authorised and filed in a timely and organised fashion.
  • Work with the other validation engineers to achieve compliance by co-ordinating each validation project assigned. The process involves the review and approval of validation documentation and co-ordination of the validation work.
  • Facilitate the PQR review process / Regulatory Review Process and Laboratory Equipment Review Process as per the current rota.
  • Keep ahead of current and changing regulatory guidance for the relevant areas of validation that applies.
  • Provide support for audit preparation, direct audit interaction and involvement in audit response.
  • Support and comply with internal EHS requirements, procedures and policies. Ensure continued conformance to EHS within the department.
  • Achieve the companies stated quality objectives through continuous improvement efforts and conformance to quality standards.
  • Attend Departmental and APEX meetings and actively participate in any Quality or Safety initiatives on site.

What Skills You Need

  • Relevant 3rd Level Qualification (Level 8 - Science/Engineering disciplines) is essential.
  • Experience in Pharmaceuticals Manufacturing/Production is essential.
  • Experience with Validations processes is essential.

What’s on Offer

  • Pension
  • Healthcare
  • 8% Annual Bonus

What’s Next

  • Apply now by clicking the “Apply Now" button or call me, Lauryn Flanagan on +353 91 455306

Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.

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