Validation Engineer

Desired Skills: Engineering,Validation,Autoclaves,Lyophilisation,HVAC,Aseptic,Compliance

*** Note: this role will be involved in site projects (e.g. re-validation projects for site expansion) – therefore, this will be a 100% onsite position. Candidates should only apply if comfortable with that ***

Top skills:

1. Autoclaves, lyophilisation, parts washers, validation execution experience.
   2. Aseptic processing validation including media fills and VHP validation execution.
   3. HVAC validation experience

VALIDATION ENGINEER

Responsibilities:

• Active participation in the ABB Validation Program and general Quality Assurance activities.
• Coordination / direction and active participation in the validation and qualification of ABB equipment, utilities, processes and software in compliance with AbbVie policies, FDA, European cGMP and GAMP
• standards.
• Generation/maintenance/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, Lyo, CIP and SIP, VHP and Temperature Mapping to meet initial validation and revalidation requirements.
• Creation/Review/Approval of various validation and qualification documents
• Management of validation, exception event, 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 maximize the effectiveness of all of the team
• members.
• Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

Requirements:

• Relevant degree and 3-5 years’ experience
• Autoclave validation execution experience
• Aseptic processing validation including media fills and VHP validation execution
• HVAC validation

Please click the link below to apply or alternatively send an up-to-date CV to howie.leahy@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***