Career Category

Job Description

Role Description

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

Senior Manager, Engineering Compliance will report to the Director, Facilities & Engineering. This role will lead a team of engineers providing oversight for the engineering compliance including quality, safety and trainings. This role requires highly cross functional interactions with key site functions to ensure success. It offers a broad exposure to all key aspects of Engineering and Facilities as well as tactical and strategic teamwork within the extended worldwide engineering network.

Responsibilities

Organizational Leadership

• Team Member of F&E Engineering Leadership Team (FELT) and ASM Site Extended Leadership Team (XLT) membership Manage staff performance and career development
• Strengthening overall functional engineering compliance capabilities

Engineering Technical Leadership:

• Providing oversight for the engineering compliance including quality, safety, and trainings.
• Provide direct leadership to complex engineering investigation and serve as escalation point for resolving process/equipment related issues, supported by a group of system owners and engineering compliance professional.
• Leads engineering audit readiness activities. Present key investigations and quality management system records in all site regulatory inspection.
• Robust support to engineering teams to perform assigned quality management activities such as deviation, change control, CAPA management
• Establishing the required processes and communications to enable effective delivery on compliance commitments
• Support Engineering safety compliance commitments and regulatory requirements
• Oversight Engineering training compliance (i.e. training need analysis, qualifications and competency) per Amgen and local regulatory requirements.
• Participate in the broader scope of Amgen global engineering network to align the engineering compliance requiremen

Talent management

• Develop a high performing team, build technical and leadership capabilities within the organization to meet current and future business needs
• Drive a culture of continuous improvement
• Coach and mentor engineers to develop their technical competency and leadership skills

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities

Basic Qualifications

• Doctorate degree in Engineering discipline or a related technical field and 2 years of directly related experience OR
• Master’s degree in Engineering discipline or a related technical field and 6 years of directly related experience OR
• Bachelor’s degree in Engineering discipline or a related technical field and/or 8 years of directly related experience
• 10 years of experience providing technical support to biologics and/or API manufacturing facilities (e.g., Engineering, Manufacturing, Maintenance & Utilities, etc.)
• Proven experience and track record of compliance in a highly regulated environment
• Demonstrated ability to effectively lead and partner in a complex, matrix environment

Preferred Qualifications

• Experience in Pharmaceutical / Biotechnology industries preferred
• Demonstrated track record in driving for results in regulated industries
• Able to communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Strong leadership skills, decision making, problem solving abilities
• Demonstrated ability to work under minimal direction
• Able to adapt to changing business needs and operational requirements
• Knowledge and experience in Lean/Six Sigma, Total Quality Management (TQM), or other continuous improvement methodology experience (e.g., DMAIC, Value Stream Mapping, Process Mapping, Reliability Centered Maintenance, Mistake-proofing, FMEA, Root Cause Analysis, etc.) are desirable skills.
• Excellent communications skills, both oral and written, including executive presentation skills
• Interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met
• Ability to work independently and collaboratively
• Ability to tactfully negotiate and positively influence peers and executive leadership
• Strong analytical skills to identify potential improvement opportunities
• Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, etc.)
• Ability to combine technical problem-solving skills with business acumen to determine best business solution