Pharma Validation Engineer – Full Lifecycle

Uniting Holding; Cork; On-site; EUR 60,000 - 90,000; Full time

Job summary

Catalyx is seeking a Validation Engineer to join our site team in Cork. You will own validation activities from planning through execution, documentation and final approval, working closely with Engineering, Manufacturing and Quality in a fast-paced GMP environment.

You will generate validation plans, author protocols, manage change controls and coordinate with QA to ensure regulatory readiness and inspections. 2–4+ years’ industry experience preferred.

Qualifications

• Hands-on validation experience in GMP pharma or biopharma.
• Experience on pharmaceutical manufacturing site with QA systems.
• Owns validation activities from planning to completion.
• Writes validation protocols and documentation, not just executing predefined protocols.
• Familiar with CAPAs, deviations and quality events.

Responsibilities

• Generate, execute and complete validation protocols and final packages across facilities, utilities and equipment, computerised systems, new product introductions and change controls.
• Develop validation plans for specific system implementation and project activities.
• Coordinate inputs and approvals across Manufacturing, Engineering, Process Sciences, QC, QA and other site functions.
• Progress change controls, deviations, quality events and CAPAs through to closure.
• Lead validation discussions in cross-functional project meetings.

Skills

GMP experience

Validation lifecycle

Change controls

QA collaboration

Regulatory awareness

Job description

Catalyx is seeking a Validation Engineer to join our site team in Cork. You will own validation activities from planning through execution, documentation and final approval, working closely with Engineering, Manufacturing and Quality in a fast-paced GMP environment.

You will generate validation plans, author protocols, manage change controls and coordinate with QA to ensure regulatory readiness and inspections. 2–4+ years’ industry experience preferred.