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Aseptic Processing Validation Manager – 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 Manager 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 Manager are to :

· Provide leadership and guidance to the validation team, with clear goals and expectations for the day-to-day activities for Validation, Re-Qualification and Periodic Review programs.

· 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.

· Manage competing priorities within the team and create an effective team environment.

· Coordinate contract personnel through completion of assignments. Raising of PO’s, negotiating with vendors and interviewing candidates.

· Manage FTE validation personnel, including organizing and prioritizing department goals & objectives, performing training, writing performance reviews, resolving people management issues for direct reports.

· Responsible for staff development, managing high performing teams, budgeting and cost control, talent mapping, succession planning, the development of strong leaders within the function.

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

· Provide department leadership and present validation packages for internal and external compliance audits as required and interfaces with regulatory agencies for the equipment validation team.

· 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, 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