Validation Engineer

PE Global (UK); Sligo; On-site; EUR 55,000 - 85,000; Full time

Job summary

ABB is seeking a Validation Engineer to drive qualification activities for equipment, utilities, and software. The role requires onsite work in Ireland, with responsibilities across validation plans, protocols, and reports to cGMP standards.

The candidate will collaborate with QA, manage vendors, and support continuous improvement in manufacturing quality, safety, and training systems. A background in aseptic validation and HVAC validation is essential.

Qualifications

• Relevant degree with 3–5 years’ experience in validation.
• Autoclave validation execution experience.
• Aseptic processing validation including media fills and VHP validation execution.
• HVAC validation experience.

Responsibilities

• Participate in the ABB Validation Program and QA activities.
• Coordinate and lead validation of ABB equipment, utilities, processes and software per cGMP.
• Create and maintain Project Validation Plans and schedules.
• Generate validation protocols and final reports to cGMP standards.
• QA support for validation investigations and corrective actions.
• Vendor supervision for validation activities.
• Execute Autoclave, Lyo, CIP and SIP, VHP and Temperature Mapping to meet validation needs.
• Document activities in line with cGMP requirements.
• Cross-train team members and train new members.
• Support continuous improvement in manufacturing, quality, safety and training systems.
• Coordinate team activities to maximize effectiveness and communicate with management.

Skills

Autoclaves

Lyophilisation

Parts washers

Education

Relevant degree

Job description

*** 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 note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***