The role
PE Global is currently recruiting for a Validation Technical Specialist on behalf of a leading pharmaceutical company based in Cork. This is an initial contract role until the end of August 2026.
Overview
The Specialist, Engineering, MS&T, Q&V will be an active member within the cross functional team providing support and guidance and will strive for technical excellence to ensure the success of the Q&V team.
Responsibilities
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.
Education and Experience
Degree in a Science or Engineering discipline.
Experience in a GMP environment essential.
Minimum 5 years’ experience in a similar role.
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 capability of working and collaborating across multiple functional teams.
Demonstrated capability to deliver results RFT, in an FDA/HPRA Regulated production environment.
Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
Interested candidates should submit an updated CV
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@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***
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