Job Description
Aseptic Processing Validation Sr. Engineer - Level 5
Ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing through sterilisation validation activities.
The role involves managing the team responsible for HVAC requalification in production environments, including routine re-qualification of airflow visualisation and filter integrity testing activities, as well as testing in response to changes to the production environment.
The activities of the Aseptic Processing Validation Sr. Engineer include supporting Operations from a Validation perspective, ensuring a Validation approach based on the best available scientific evidence and professional judgment, and developing internal policies and procedures associated with maintenance of the Site Validation Master Plan and Requalification Plans.
The role also involves managing and coordinating the aseptic process simulation program, supporting airflow visualisation studies and HVAC requalification program, collating and reporting on relevant validation data and metrics, and providing validation support for Amgen's quality management system.
Key responsibilities also include participating and delivering regulatory filings and RTQs for validation, providing expert technical validation support, and working on moderately complex to complex problems, requiring in-depth evaluation of various factors.
The successful candidate will have a Master's degree with 5+ years of experience in validation, engineering, or a related field, or a BS degree with 7+ years of experience in a related field.
PREFERRED QUALIFICATIONS:
• In-depth understanding and application of validation principles, concepts, practices, and standards.
• Extensive working knowledge of sterilisation/decontamination systems and industry practices.
• Experience working with critical HVAC systems and qualification of AVS.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Ability to think critically with demonstrated troubleshooting and analytical skills.
• Previous people management experience highly desired.