Validation Engineer

Gertek Project Management; Sligo; On-site; EUR 65,000 - 90,000; Full time

Job summary

GerTEK is seeking a Validation Engineer to support validation programs across equipment, utilities and processes within a life science manufacturing context. The role involves creating and executing validation plans, protocols and reports in line with cGMP standards.

You will assist with investigations, CAPAs and change control while coordinating vendor activities and ensuring training and continuous improvement within the team.

Qualifications

• Relevant degree and 5 years' experience.
• Autoclave validation execution experience (preferred).
• Aseptic processing validation including media fills and VHP validation execution (preferred).
• HVAC validation (preferred).

Responsibilities

• Active participation in the Validation Program and QA activities.
• 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 corrective actions.
• Vendor supervision for validation activities.
• Execution of Autoclave, Parts washer, Lyo, CIP and SIP, VHP and Temperature Mapping for validation needs.
• Creation/Review/Approval of validation documents; management of validation, exceptions, and change control.
• Documenting all activities in line with cGMP requirements.
• Cross training within the team and training of new members.
• Participation in continuous improvement programs to enhance manufacturing, quality, safety and training systems.

Skills

Validation

Quality Assurance

cGMP

GAMP

Education

Relevant degree

Tools

Autoclave

Media fills

VHP validation

HVAC validation

Job description

Job Description

GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects. VALIDATION ENGINEER Responsibilities: Active participation in the 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 policies, FDA, European cGMP and GAMP 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 Documenting all activities in line with cGMP requirements. Performing cross training within the team and training of new team 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 Communicating with peers and management regarding activities in the area, including elevation of events or concerns. Qualifications: Relevant degree and 5 years' experience Autoclave validation execution experience (prefferrd) Aseptic processing validation including media fills and VHP validation execution (prefferred) HVAC validation (prefferred) #Gertek