Our client, a global healthcare leader is currently recruiting for a Validation Engineer to join their growing team in Westport, Co. Mayo on an initial 6-month contract. The Validation Engineer will ensure customer satisfaction is delivered with each revalidation, validation and project work.
Responsibilities (Full job description available on request):
As a Validation Engineer you will be responsible for the following:
Over-see, coordinate, guide and implement the site validation master under prospective, concurrent, and retrospective validation studies in a timely manner, with the relevant engineers. To ensure that all validation requirements are met for any new process, equipment or change to existing process or equipment.
To actively work on validation projects, being the departmental point person and completing all associated project documentation in line with current corporate and regulatory expectations.
Participate in risk assessment process for all business units & participate in design review process for all business units.
Tracking and generation of weekly metrics (GTW QMS, EHS, Compliance Wire etc.)
To facilitate the PQR review process / Regulatory Review Process and Laboratory Equipment Review Process as per the current rota’s.
Keep abreast 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.
Provide support for audit preparation, direct audit interaction and involvement in audit response. Participation in site internal and external audit program (to include periodic review).
Ideal background:
Bachelor’s degree required in science based or engineering discipline.
Experience in Pharmaceutical company.
Excellent project management skills.
Proficient in use of Microsoft Office suite of programs.
Ability to articulate clearly when dealing with internal and external bodies.
Expertise in the relevant subject matter areas – example Equipment, Facility, Aseptics, Process, CPV, CSV, Cleaning.
For a confidential discussion and more information on the role, please contact Sarah Flynn
sarah.flynn@collinsmcnicholas.ie
+353 719108060