Manager QC Equipment Maintenance

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

QC Manager- Equipment Maintenance

What you will do

Let’s do this! Let’s change the world!

In this vital role the Equipment Manager will supervise a team responsible for maintenance of Quality Control (QC) equipment at Amgen Rhode Island (ARI). This role is integral in fostering and further developing the culture of Safety, Quality, and Lean Leadership within the organization.

• Provide direct oversight to a team responsible for core QC equipment maintenance and system ownership.

• Manage the end-to-end life cycle for QC equipment, including: Procurement, Development and execution of validation and change control strategy/ownership, General and corrective maintenance activities, Decommissioning as required.

• Serve as Site SME/Representative on QC System Owner Network by fielding requests, providing advice to other sites, and alignment decisions with other sites

• Serve as owner of the ARI Master List for QC Equipment and Computerized Analytical Lab Systems List

• Ensure compliance with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety protocols, Laboratory controls

• Provide support for audits and inspections. May include interaction with regulatory agencies, partner organizations, and internal audit functions during on-site inspections and audits.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Quality or Equipment Management experience OR

• Associate’s degree and 10 years of Quality or Equipment Management experience OR

• Bachelor’s degree and 5 years of Quality or Equipment Management experience OR

• Master’s degree and 3 years of Quality or Equipment Management experience OR

• Doctorate degree

Preferred Qualifications:

• Bachelor’s degree in a related field; advanced degree preferred.

• Proven experience in QC equipment management and laboratory operations.

• Strong leadership skills with a focus on safety, quality, and lean principles.

• Excellent communication and interpersonal skills.

• Ability to work collaboratively across multiple sites and teams.

• Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources

• Experience with equipment procurement, development and execution of validation, general and corrective maintenance activities

• Excellent interpersonal, written and verbal communication skills with all levels within the organization

• Ability to work in a team matrix environment and build relationships with partners

• Identify, manage, and champion innovative projects to advance productivity and enable LEAN principles across different functions

• Experience with supporting staff training, career development and performance management

• Establishment and tracking of department goals, strategies and KPIs

• Experience in auditing and defending processes, procedures and decisions during regulatory inspections

• Experience with various laboratory equipment and computer systems

• Strong leadership and negotiation skills with an ability to influence different styles

• Demonstrated innovative thinking and ability to transform work organizations

• Exposure to Operational Excellence initiatives

• Ability to