Validation Sr. Engineer - Aseptic Processing

Career Category

Engineering

Job Description

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.   

 

The activities of the Aseptic Processing Validation Sr. Engineer

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·         Support Operations from a Validation perspective to deliver and maintain equipment in a qualified state in the most efficient manner possible. Ensure Validation approach is based on the best available scientific evidence and professional judgment in collaboration with the Validation network.

·         Develop and ensure internal policies, procedures and practices associated with maintenance of the Site Validation Master Plan and Requalification Plans specific to area of responsibility. 

·         Responsible for managing and co-ordinating the aseptic process simulation program, including aseptic intervention review, protocol and summary report review, MES hold time support.

·         Responsible for supporting for airflow visualisation studies and HVAC requalification program.

·         Collate and report on relevant validation data and metrics.

·         Provide validation support for Amgen’s quality management system, including change control, deviation and CAPA processes.

·         Participate and deliver regulatory filings and RTQ’s for validation.

·         Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process. 

·         Work on moderately complex to complex problems, where analysis of situations or data requires in-depth evaluation of various factors. Strong judgment is required in resolving problems and making recommendations.

·         Writes and/or implements, owns and approves changes to controlled documents (e.g., SOPs, Specifications, Master Protocols, etc.) as needed.

·         Support senior leadership in creating and implementing mid to long- term plans for department.

·         Demonstrate ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.

·     ·   Ensure projects and routine work are executed safely, efficiently, and in accordance with all applicable codes and Amgen Standards.

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·         Review and approves protocols, reports and data tables generated by staff and contract personnel.

 

Basic Qualifications:

·         Master’s degree with 5+ years of experience in validation, engineering Or

·         BS degree with 7+ years of experience in Validation, Engineering, Microbiolo