Senior Validation Engineer Role
This role requires a Senior Validation Engineer to lead the planning and execution of qualification and validation activities for critical equipment at our site. A primary focus will be HVAC qualification and validation within our production environments, including managing routine re-qualification programs for airflow visualization, filter integrity, velocity, and particle monitoring.
The ideal candidate will have 5+ years of experience in a similar role within a regulated environment and strong knowledge of cGMPs and other worldwide regulatory requirements. Direct experience qualifying HVAC systems and/or executing VPHP qualifications is preferred.
Key Responsibilities
- Provide technical validation support across the full validation lifecycle process to meet site objectives.
- Develop, review, and approve essential validation documentation, including plans, protocols, and discrepancy summary reports.
- Lead the execution of HVAC-related testing: airflow visualization, filter integrity, velocity, and particle monitoring.
- Lead the execution of cycle development, performance qualifications, and requalification programs for VPHP isolators.
- Collect and report relevant validation data and metrics.
- Help improve and develop the validation lifecycle process, ensuring adherence to all applicable regulations and standards.
- Support quality management by assisting with change control, deviation, and CAPA processes.
- Coordinate projects and prioritize workload to align with site priorities.
- Participate in multidisciplinary teams and maintain validation Standard Operating Procedures (SOPs) according to site and corporate requirements.
- Comply with safety statements and champion safe working practices.