Senior Validation Engineer

Assignment length: 12 months initially

You'll play a critical role in maintaining compliance and supporting our dynamic Drug Product Manufacturing operations.

The Validation department is crucial for ensuring the integrity of our drug product manufacturing. We handle equipment, utility, facility, cleaning, and sterilization validation activities to meet stringent company procedures and industry standards.

The Role

This includes managing routine re-qualification programs for airflow visualization, filter integrity, velocity, and particle monitoring. You'll also conduct testing in response to changes and expansions within the production environment. This role may also support the (re)qualification of other critical equipment on site, such as Isolators and E-Beams, as needed.

• 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 Amgen standards.
• Support Amgen's quality management system by assisting with change control, deviation, and CAPA processes.
• Coordinate projects and prioritize your workload to align with site priorities.
• Participate in multidisciplinary site and multisite teams, including cross-functional investigation teams and change control.
• Update and maintain validation Standard Operating Procedures (SOPs) according to site and corporate requirements.
• Comply with site safety statements and champion safe working practices.

• Bachelor of Science/Engineering degree or equivalent.
• 5+ years of experience in a similar role within a regulated environment.
• Strong knowledge of cGMPs and other worldwide regulatory requirements.
• Proven problem-solving ability and excellent oral and written communication skills.

• Direct experience qualifying HVAC systems and/or executing VPHP qualifications.
• Familiarity with Quality and Document Management Systems (e.g., Trackwise Deviations, CAPA, Change Controls, Maximo, CDOCs, Kneat).
• Independent, self-motivated, proactive, and organized, with the ability to multi-task effectively in project environments.
• A true team player, ready to contribute to a collaborative, team-based culture.