Equipment Validation Manager – Level 5

　　The equipment validation department performs equipment 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.

　　The activities of the Equipment Validation Manager are to :

　　Provides leadership and guidance to equipment validation team, with clear goals and expectations for the day-to-day activities for Equipment Qualification and Periodic Review programs.

　　Develops and ensures internal policies, procedures and practices associated with maintenance of the Site Validation Master Plan based on the best available scientific evidence and professional judgment in collaboration with the C&Q and Validation network

　　Works 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.

　　Supports senior leadership in creating and implementing mid-long term plans for department.

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

　　Ability to liaise with Engineering, Commissioning and Qualification, and external vendors regarding equipment User Requirement Specifications, Factory acceptance tests to ensure the quality by design principles are being followed.

　　Demonstrates ability in managing competing priorities, creating an effective team environment.

　　Independently manages assigned projects through completion, includes managing audit support as required.

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

　　Manages 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.

　　Participate and deliver in regulatory filings and RTQ’s for equipment validation.

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

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

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

　　Contributes directly to the completion of projects through the development/review/approval of validation schedules, project plans, change controls, specifications, master plans, validation protocols and reports for systems that may be complex in nature to support commercial manufacturing.

　　Provides technical assessment and validation approval for engineering and process changes.

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

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

　　Basic Qualifications:

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

　　BS degree with 7+ years of experience in validation, engineering 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, including qualifying filling, formulation and packaging systems.

　　Extensive working knowledge of equipment and systems and industry practices.

　　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

　　In depth experience in equipment qualification and the validation lifecycle process in line with ASTM E2500.