Equipment Validation Engineer required for a leading Biotech facility in Co. Cork
to Lead/Execute/Participate in Equipment and System Validation Lifecycle processes. Initially a 7 month contract.
ROLE
Lead/Execute/Participate in Equipment and System Validation Lifecycle processes, Qualification (IQ/OQ/PQ), Revalidation, Requalification and Equipment Periodic Reviews, for Equipment and Systems.
Coordinate with and guide other departments or outside contractors/vendors to complete validation tasks.
Participate in CSV Validation Lifecycle processes, Qualification (RS/QAP/UAT etc), CSV Periodic Reviews, for Equipment and Systems.
Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
Execute/Participate in change controls and other compliance related tasks e.g. non-conformances.
Support regulatory audits.
Lead/Support Shipping Qualification and/or Cleaning Verification/Validation activities.
Work on own initiative to maintain adherence to schedule of activities including run the business and project workloads.
Support, lead or guide others in CQV projects.
Requirements:
Minimum 5 years' experience in a similar role.
Hon. Degree in a Science or Engineering discipline.
Experience in a GMP environment essential.
Demonstrated knowledge in pharmaceutical/biopharmaceutical technical manufacturing operations, with experience of successfully delivering technical projects.
Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory.
Demonstrated high level of complex problem solving and attention to detail.
Demonstrated capability of working and collaborating across multiple functional teams.
Demonstrated capability to deliver results RFT, in an FDA/HPRA Regulated production environment.
Skills
Equipment Engineer
Validation
Biotech
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