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Senior Equipment Validation Specialist
3 weeks ago
We are seeking a seasoned Lead Validation Engineer to spearhead the validation and qualification of equipment and processes. This is a critical role that requires expertise in Computer System Validation (CSV), process validation, and automation process validation.
About the Role:- Spearhead the overall validation & qualification of the equipment and processes.
- Develop the overall validation and qualification plan/strategy in compliance with onsite governing procedures.
- Collaborate with the QA Team to ensure there is agreement to the overall strategy.
- Lead/develop the vision attribute agreement analysis test criteria.
- Action plan developed for each of the key deliverables.
- Process/Equipment Validation experience with CSV knowledge.
- Background in automation process validation, with an understanding (not expertise) of CSV.
- Familiarity with GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
- Understanding of the regulatory requirements related to electronic records and signatures.
- Familiarity with ISO 9001, ISO 13485 (for medical devices), and ISO/IEC 27001 (for information security).
- Knowledge of the entire lifecycle from planning, execution, and reporting.
- Strong understanding of CSV processes, including risk-based approach, qualification testing, validation protocols, and traceability matrix development.
- Skills in validating interfaces between different systems.
- Experience with software test methodologies (e.g., functional, performance, stress testing).
- Creating and maintaining validation documentation such as protocols, reports, and deviations.
- Competitive salaries.
- Pension.
- Health care.
- Life insurance.
- Laptop.
- Phone.
- Access to extensive training resources.
- Company discounts.
- On-site parking.
- Eligible to work in Ireland/EU.
