Lead Validation Engineer

Methodius Ltd; Limerick; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading company is seeking a skilled Lead Validation Engineer to support the transition from manual to automated validation methods. The role involves creating validation strategies, guiding documentation for regulatory compliance, and ensuring oversight of validation activities in a cutting-edge technology environment.

Benefits

Competitive salaries

Pension

Healthcare

Life insurance

Company laptop and phone

Extensive training resources

Discounts

On-site parking

Qualifications

• Experience in Process/Equipment Validation with strong CSV knowledge.
• Understanding of GxP guidelines like GMP, GLP, and GCP.
• Familiarity with FDA regulations and ISO standards.

Responsibilities

• Lead validation and qualification of equipment and processes.
• Create quality validation processes and documentation.
• Collaborate with QA to ensure validation strategies.

Skills

Process/Equipment Validation

CSV knowledge

Automation process validation

GxP guidelines (GMP, GLP, GCP)

FDA 21 CFR Part 11

ISO standards (9001, 13485, 27001)

Validation lifecycle management (IQ, OQ, PQ)

System integration and interface testing

Software testing methodologies

Validation documentation and technical writing

Job description

My client is currently looking for a Lead Validation Engineer to join their growing team.

You’ll use your skills in a cutting-edge technology environment. This is an exciting opportunity which will enable you to grow your technical skill set.

The validation lead should be able to guide the team in creating the master validation plan (MVP), validation strategy, and validation output documents (FAT, SAT, IQ, OQ, PQ) aligning with business SOPs. The client is seeking to validate a new machine that will inspect the IOL. Understanding of CSV/software in a machine will be needed. Someone with experience in validation of capital equipment would be ideal for this role.

The Job

Supporting validation from an automation perspective. Actively guiding the site in transitioning from manual to automated validation methodologies, including the development of the corresponding lifecycle validation documentation and supporting IQ, OQ, PQ activities. Collaborating with a CSV-specific resource is required, so understanding CSV is important.

Have full technical oversight and lead the validation and qualification of equipment and processes. Develop validation and qualification plans/strategies in compliance with site procedures and in alignment with the engineering and technology departments. Create quality validation process flows, including documentation for regulatory submissions. Promote a common approach to validation documentation and strategies.

Lead, support, guide, and coordinate validation activities, ensuring resource allocation, task prioritization, and progress monitoring. Collaborate with QA to ensure agreement on strategies, resolve issues, and complete project tasks. Lead the development of validation test criteria such as linearity and bias.

Develop action plans for key deliverables, including FAT & SAT protocols and reports, IQ/OQ/PQ testing, and validation of new machines inspecting IOLs.

Key skills / experience:

• Process/Equipment Validation experience with CSV knowledge.
• Background in automation process validation with understanding of CSV.
• Knowledge of GxP guidelines such as GMP, GLP, and GCP.
• Understanding of FDA 21 CFR Part 11 regulations.
• Familiarity with ISO standards like ISO 9001, ISO 13485, and ISO/IEC 27001.
• Experience with validation lifecycle management, including IQ, OQ, PQ.
• Strong understanding of CSV methodologies, risk-based approaches, and validation protocols.
• Skills in system integration and interface testing.
• Experience with software testing methodologies.
• Proficiency in validation documentation and technical writing, including protocols and reports.

This position is based full-time in Limerick City. It is a permanent role offering competitive salaries, pension, healthcare, life insurance, a company laptop and phone, extensive training resources, discounts, on-site parking, and more.

The candidate must be eligible to work in Ireland/EU.

Please contact David Coyle at 01 6351748 or email [e-mail].