Validation Manager Job at Amgen (Dun Laoghaire)

Job Description

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 within the Aseptic Process Validation team. The Aseptic Process Sterilisation team perform validation/ re-qualification on critical GMP equipment such as critical HVAC systems -airflow visualisation and filter integrity testing activities, VPHP isolators, autoclaves, SIP systems, Lyophilisers as well as testing in response to changes to the production environment.The team also provide validation oversight on aseptic processing simulations (APS). Depending on experience, this role will manage a team responsible for the re-qualification team within some of these areas.

Job Responsibility

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
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
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
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
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

Requirements

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

Nice to have

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

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Validation Manager

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