Validation Engineer
2 weeks ago
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:
1. Lead commissioning, qualification, and validation (CQV) activities for Vial and Syringe Filling operations, including:
2. Sterile operations (Isolators, VHP, decontamination systems)
3. Cleaning and sterilization validation (Autoclaves, Single-Use Technologies)
4. Filter and formulation process validation (DeltaV systems)
5. Equipment qualification (tube welders, sealers, automated inspection systems)
6. Oversee Operational Qualification (OQ) through to Product Qualification (PQ).
7. Act as Validation SME, ensuring alignment with site and regulatory requirements.
8. Coach and manage validation engineers, providing technical oversight for C&Q activities.
9. Support tech transfer and liaise with cross-functional teams to ensure product requirements are met.
10. Own and execute updates to SOPs and QMS-related change controls.
Experience & Skills Required:
1. Minimum 6 years in C&Q/QA/Validation within a regulated industry.
2. At least 2 years of equipment qualification experience on large-scale projects.
3. Expertise in Vial & Syringe Filling, cleaning/sterilization validation, and sterile processing technologies.
4. Proven experience in regulatory submissions and defending validation approaches.
5. Strong working knowledge of ASTM E2500, FDA/EU GMPs, and ISPE guidelines.
6. Demonstrated leadership, project management skills, and ability to coach multidisciplinary teams.
7. Preferred Qualifications:
8. Degree in Pharmaceutical, Biological, Chemical Sciences, or related Engineering fields.
9. Experience with DeltaV systems, technology transfers, and regulatory filing processes.
10. 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
#J-18808-Ljbffr
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