Career Category

Maintenance

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Maintenance Manager

Live

What you will do

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

In this dynamic role you will ensure reliable equipment and facility performance by improving uptime and enabling integration of new technologies to advance Amgen’s clinical and commercial products' supply. This position is a managerial role with direct reports, and responsible for staff development, leadership, technical direction, and strategy deployment for driving forward operational excellence in a broad array of Drug product Equipment.

Responsibilities include:

• Provide tactical as well as strategic management and leadership to provide operational support and projects implementation, mentoring, staff development, team productivity and efficient use of available resources. Providing input into department objectives and establishment of strategic direction within the Drug product F&E team.

• Ensures that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations and specifications

• Ensures that manufacturing facilities, equipment, processes, and procedures are aligned with cGMP requirements and/or other applicable regulations

• Work with diverse groups (Manufacturing, Quality, PD, Automation, IS, EHSS, Global Engineering etc) within the organization and drive new business processes to ensure continuous and sustained improvements.

• Ensure site readiness and compliance for internal audits, external agency audits, and partner audits. Ensure safety of all personnel during plant operations and engineering activities.

• Ensure that all staff are adequately trained and aligned with all GMP standards and procedures

• Develop and stay within department budgets and spend for operational and capital expenses.

• Ensures GMP activities for assigned Operations function follow approved GMP procedures and are detailed according to cGMP and/or GDP requirements. May also complete these GMP tasks

• Responsible for ensuring that risks are identified, assessed, and corrected to ensure the safety, purity, quality, and efficiency of the product(s) manufactured

• May be required to own or provide subject matter expertise to nonconformance investigations, corrective and preventive actions, change control records or validations

• Ensures that non-conformances for areas of responsibility are reported promptly to the Quality unit and investigated per procedures

• Ensures that corrective actions and preventive actions (CAPA) are handled and closed according to procedures

• Ensure document periodic review activities are completed on time for documents owned by assigned areas of responsibility.

• Provides input for Management Reviews

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Maintenance Manager we seek is a leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Maintenance experience OR

• Associate’s degree and 10 years of Maintenance experience OR

• Bachelor’s degree and 5 years of Maintenance experience OR

• Master’s degree and 3 years of Maintenance experience OR

• Doctorate degree

• In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• Prior experience leading maintenance teams or other technical professionals

• 5+ years' experience in Biopharmaceutical operations

• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation

• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as filling, isolators, lyophilization, cappers, inspection as well as other equipment and utilities needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, tunnels, clean steam, water for injection, etc. Knowledge of SU systems and assemblies.

• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)

• Understanding of the implementation process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation

• Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.

• Understand regulatory trends in the industry. Direct experience with FDA or equivalent regulatory body

• Independent, self-motivated, organized, ability to handle multiple resource demands and prioritization, assess project efficiency, and skilled in communication, facilitation, and collaboration

• Standout colleague prepared to work in and adopt a team-based mentality that relies on collaboration for effective decision-making

• Strong leadership, technical writing, and communication/presentation skills

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Salary Range

108,226.00 USD - 138,188.00 USD