Description
PE Global is currently recruiting for a Validation Engineer on behalf of a leading biologics company based in Sligo. This is an initial contract role until the end of December 2026.
Responsibilities
Active participation in the Validation Program and general Quality Assurance activities.
Coordination and direction, and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards.
Generation, maintenance and execution of Project Validation Plans and schedules.
Generation of validation protocols and final reports to cGMP standards. QA support for validation investigations and implementation of corrective actions.
Vendor supervision for execution of validation activities.
Execution of Autoclave, parts washer, lyophilisation (Lyo), CIP and SIP, VHP and temperature mapping to meet initial validation and revalidation requirements.
Creation, review and approval of various validation and qualification documents.
Management of validation, exception events and change control processes.
Documenting all activities in line with cGMP requirements.
Performing cross training within the team and training of new team members.
Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
Coordinating activities to maximise the effectiveness of all team members.
Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
Education and Experience
Relevant degree and 5 years’ experience.
Autoclave validation execution experience.
Aseptic processing validation including media fills and VHP validation execution.
HVAC validation experience.
Interested candidates should submit an updated CV.
***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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