Validation Engineer

Quanta Consultancy Services Ltd; Connacht; On-site; EUR 45,000 - 65,000; Full time

Job summary

Quanta Consultancy Services Ltd is seeking a Validation Engineer for a County Mayo, Ireland based initial 4‑month contract in the life sciences sector. The role involves coordinating the validation and qualification of equipment, utilities, processes and software in line with FDA, European cGMP and GAMP standards.

You will generate validation plans, write protocols and final reports to cGMP standards, provide QA support for investigations, supervise vendors, and execute autoclave, aseptic, HVAC

Qualifications

• Autoclave validation execution experience.
• Aseptic processing validation including media fills and VHP validation execution.
• HVAC validation experience is required.

Responsibilities

• Coordinate/lead validation and qualification of equipment, utilities, processes and software to meet cGMP and GAMP standards.
• Generate and maintain Project Validation Plans and schedules.
• Create validation protocols and final reports to cGMP standards.
• Provide QA support for validation investigations and corrective actions.
• Supervise vendors for validation activities.
• Execute validation activities such as Autoclave, Lyo, CIP/SIP, VHP and Temperature Mapping.

Skills

Autoclave validation

Aseptic processing validation

HVAC validation

Education

Relevant degree

Job description

Validation Engineer – County Mayo, Ireland – Initial 4-Month Contract – Life Sciences

Located near Mayo, our global pharmaceutical client is seeking a Validation Engineer to support their state‑of‑the‑art manufacturing facility. The company focuses on investing in research and development to drive scientific innovation and deliver life‑changing medicines. With project worldwide and continued growth across their network, this is an excellent opportunity to support a leading organisation shaping the future of healthcare.

What you’ll deliver:

• Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software, 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.

Experience required:

• Relevant degree and extensive experience
• Autoclave validation execution experience
• Aseptic processing validation including media fills and VHP validation execution
• HVAC validation