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Validation Engineer

  • Sector: Engineering
  • Contact Email: kevin.griffin@collinsmcnicholas.ie
  • Job Ref: 23800

Overview:

Join the Multinational Pharmaceutical site during its significant expansion as a Validation Engineer (CQV). This is a unique opportunity to transition the new facility from construction to a fully operational site delivering life-saving pharmaceutical products.

Key Responsibilities:

  • Lead commissioning, qualification, and validation (CQV) activities for Vial and Syringe Filling operations, including:

  • Sterile operations (Isolators, VHP, decontamination systems)

  • Cleaning and sterilization validation (Autoclaves, Single-Use Technologies)

  • Filter and formulation process validation (DeltaV systems)

  • Equipment qualification (tube welders, sealers, automated inspection systems)

  • Oversee Operational Qualification (OQ) through to Product Qualification (PQ).

  • Act as Validation SME, ensuring alignment with site and regulatory requirements.

  • Coach and manage validation engineers, providing technical oversight for C&Q activities.

  • Support tech transfer and liaise with cross-functional teams to ensure product requirements are met.

  • Own and execute updates to SOPs and QMS-related change controls.

Experience & Skills Required:

  • Minimum 6 years in C&Q/QA/Validation within a regulated industry.

  • At least 2 years of equipment qualification experience on large-scale projects.

  • Expertise in Vial & Syringe Filling, cleaning/sterilization validation, and sterile processing technologies.

  • Proven experience in regulatory submissions and defending validation approaches.

  • Strong working knowledge of ASTM E2500, FDA/EU GMPs, and ISPE guidelines.

  • Demonstrated leadership, project management skills, and ability to coach multidisciplinary teams.

  • Preferred Qualifications:

  • Degree in Pharmaceutical, Biological, Chemical Sciences, or related Engineering fields.

  • Experience with DeltaV systems, technology transfers, and regulatory filing processes.

  • Knowledge of sterile processing, HVAC, clean utilities, and high-potency containment methodologies is advantageous.

For a confidential discussion and more information on the role, please contact Kevin Griffin.

kevin.griffin@collinsmcnicholas.ie

(021) 2427108