Validation Engineer (CQV) - Join Our Team in the Multinational Pharmaceutical Site
We are currently seeking a skilled Validation Engineer (CQV) to lead our new facility from construction to a fully operational site delivering life-saving pharmaceutical products.
About This Role:
This is an exciting opportunity for someone with experience in commissioning, qualification, and validation of Vial and Syringe Filling operations. You will be responsible for ensuring the site meets regulatory requirements and that all equipment is qualified and validated.
* Lead CQV activities for Vial and Syringe Filling operations, including sterile operations, cleaning and sterilization validation, filter and formulation process validation, equipment qualification, and Operational Qualification through to Product Qualification.
* Act as a 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.
Key Responsibilities:
CQV Activities:
You will be responsible for leading commissioning, qualification, and validation activities for Vial and Syringe Filling operations. This includes:
* 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
Regulatory Compliance:
You will be responsible for ensuring the site meets regulatory requirements, including FDA/EU GMPs and ISPE guidelines.
Requirements:
To be successful in this role, you will need:
* Minimum 6 years of experience 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:
Prior experience with DeltaV systems, technology transfers, and regulatory filing processes is advantageous. Knowledge of sterile processing, HVAC, clean utilities, and high-potency containment methodologies is also beneficial.