Lead Validation Engineer

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 creating the validation output document (FAT, SAT, IQ OQ PQ) aligning to business SOPs. The client is seeking to validate a new machine which will inspect the IOL. Understanding of CSV/software in a machine will be needed. Someone who has experience with the 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. This includes the development of the corresponding life cycle validation documentation and actively supporting the IQ | OQ | PQ. Collaborating with a CSV-specific resource (assigned). Therefore, understanding CSV is important.

Have full technical oversight and lead the overall validation & qualification of the equipment and processes. Develop the overall validation and qualification plan/strategy in compliance with onsite governing procedures and aligned with the engineering Technology department, delivering the overall project. Create quality validation process flow (e.g., V up to and including Regulatory submission). Promote and support an effort to have a common approach to documentation and strategies.

Lead, support, guide, and coordinate validation activities with the team members to ensure adequate resource assignment, task prioritization, and progress monitoring according to schedule. Collaborate with the QA Team to ensure there is agreement to the overall strategy, resolve any issues that arise, and work through the tasks to complete the overall project. Lead/develop the vision attribute agreement analysis test criteria, e.g., Linearity & Bias etc.

Action plan developed for each of the key deliverables. FAT & SAT Protocol Report and Test Plan Report completed. Lead the execution of IQ, OQ & PQ Testing. IQ | OQ | PQ Documentation Report completed. Validate a new machine which will inspect the IOL. Validation of capital equipment.

Key Skills / Experience:

Must have: Process/Equipment Validation experience with CSV knowledge. Background in automation process validation, with an understanding (not expertise) of CSV. Understanding of the CSV/software in a machine will be needed. Validation and Compliance Knowledge.

GxP Guidelines: Familiarity with GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).

FDA 21 CFR Part 11: Understanding of the regulatory requirements related to electronic records and signatures.

ISO Standards: Familiarity with ISO 9001, ISO 13485 (for medical devices), and ISO/IEC 27001 (for information security).

Validation Lifecycle Management: Knowledge of the entire lifecycle from planning, execution, and reporting, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).

Computer System Validation (CSV) Expertise: Strong understanding of CSV processes, including risk-based approach, qualification testing, validation protocols, and traceability matrix development.

System Integration & Interface Testing: Skills in validating interfaces between different systems, including ensuring data integrity during integration.

Software Testing: Experience with software test methodologies (e.g., functional, performance, stress testing).

Documentation & Reporting: Creating and maintaining validation documentation such as protocols, reports, and deviations. Proficiency in technical writing is key.

Based in Limerick City full time. Permanent Role. They offer competitive salaries, including pension, health care, life insurance, laptop, phone, access to extensive training resources, company discounts, on-site parking, and more.

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

Please do not hesitate to contact David Coyle at 01 6351748 or email david@methodius.com

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