Company
Biologics Drug Product Manufacturing
AsepticProcessingValidationManager
Neural analysis suggests this role is
optimal for Mid candidates.
“Aseptic Processing Validation Manager. Skills: Validation, Aseptic Processing, Sterilisation Systems, People Management. Provide leadership and guidance. Support Operations from Validation perspective”
What You'll Achieve.
Deliver and maintain equipment in a qualified state; Ensure Validation approach is based on scientific evidence; Meet site objectives; Achieve department goals & objectives
Industry & Context.
Facilitate problem solving; Troubleshooting; Analytical skills
What They're Looking For.
Must Have
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
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, 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.
What You'll Do.
Provide leadership and guidance
Support Operations from Validation perspective
Develop and ensure internal policies
Manage and co-ordinating aseptic process simulation program
Collate and report on validation data
Provide validation support for quality management system
Participate and deliver regulatory filings
Provide expert technical validation support
Work on moderately complex to complex problems
Writes and/or implements
owns and approves changes
Support senior leadership in creating plans
Demonstrate ability to successfully interact with other functions
Manage competing priorities within the team
Coordinate contract personnel
Manage FTE validation personnel
Responsible for staff development
Ensure projects and routine work are executed safely
Provide department leadership and present validation packages
Review and approves protocols
reports and data tables
How You'll Work.
Team & Collaboration
Interact with other functions on projects; Negotiation and collaboration with cross-functional peers; Create an effective team environment; Present validation packages for audits; Interface with regulatory agencies
Communication Scope
Excellent interpersonal, verbal, and written communication skills; Able to express ideas and present information effectively
Process & Methodology
Program management, Change management
Full Job Description
## **Career Category** Engineering ## ## **Job Description** **Aseptic Processing Validation Manager** 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. **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. · Collate and report on relevant validation data and metrics. · Provide validation support for Amgen’s qualit
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