Sr. Validation Engineer - Aseptic Processing

at  Amgen

ASEPTIC PROCESSING VALIDATION SR. ENGINEER – LEVEL 5

The validation department performs sterilisation validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing.
An exciting opportunity has arisen for a Sr. Engineer for the HVAC /AVS (Airflow Visualisation)/APS (Aseptic Process Simulation/media fill) Validation team within the Aseptic Process Validation team.
The Aseptic Process Sterilisation team perform /validation/ re-qualification on equipment such as VHP isolators, autoclaves, CIP/SIP systems and Lyophilisers and provide validation oversight on aseptic processing simulations.
This role will focus on managing the team responsible for HVAC requalification in the production environments, including managing the routine re-qualification program of airflow visualisation and filter integrity testing activities as well as testing in response to changes to the production environment.

BASIC QUALIFICATIONS:

• Master’s degree with 5+ years of experience in validation, engineering Or
• BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality

PREFERRED QUALIFICATIONS:

• In-depth understanding and application of validation principles, concepts, practices, and standards.
• In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing
• Extensive working knowledge of sterilisation/decontamination systems and industry practices.
• Experience working with critical HVAC systems and qualification of AVS
• Experience with APS
• Demonstrate active listening and continuous feedback within team, ability to facilitate problem solving, decision making, and issue resolution
• Strong program and change management skills
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced, dynamic, and highly fluid company environment with works under consultative direction toward pre-determined long-range goals and objectives.
• Able to adjust workload based upon changing priorities
• Previous people management experience highly desired.
• Able to express ideas and present information effectively to Amgen leadership, within team functions, and with external partners
• Ability to think critically with demonstrated troubleshooting and analytical skills

Please refer the Job description for details