Senior Manager Utilities Engineering

BioSpace; Holly Springs (NC); Hybrid; USD 140,000 - 180,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based long-term incentives

Flexible work models including remote/

Job summary

Amgen in North Carolina is seeking a Senior Manager Utilities Engineering to lead the Utilities Engineering teams within the Facilities & Engineering (F&E) group, reporting to the F&E Director. In this critical role, you will guide the utilities engineering staff and ensure 24/7 operations across site utility systems at the Holly Springs facility.

You will own GMP utilities such as PW, WFI, Clean Steam, and Process Gases, drive long-term maintenance strategies, ensure cGMP

Qualifications

• Doctorate/masters/bachelors with required engineering experience and managerial experience
• High level engineering qualification with leadership responsibilities
• Multiple acceptable education pathways with increasing depth of study
• Senior leadership experience in a regulated manufacturing environment
• Experience managing utilities engineering teams and budgeting processes

Responsibilities

• Site design, construction, start-up, and operational readiness for utilities.
• Build and lead Utilities Engineering teams; provide technical leadership.
• Develop and implement long-term strategy for installed systems and equipment including CMMS.
• Ensure cGMP compliance and safety across activities and personnel.
• Lead 24/7 plant and utility coverage and coordinate with cross-functional teams.
• Oversee GMP utilities (PW, WFI, Clean Steam, compressed air, process gases) and non-GMP utilities.
• Manage system ownership, spare parts, maintenance programs, and supplier management.

Skills

Managerial experience

Leadership

24/7 operations

Stakeholder collaboration

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel likeyourepart of something bigger,itsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980,wevehelped pioneer the world of biotech in our fight against the worlds 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,youllhelp 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 thatliewithin them,youllthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Manager Utilities Engineering

What you will do

Lets do this! Lets change the world! The Senior Manager Utilities Engineering will join the Facilities & Engineering (F&E) group reporting to the Facilities & Engineering (F&E) Director. In this vital role, you will lead the Utilities Engineering teams andwill provide technical leadership to the utilities engineering team while supporting 24/7 operations.

Job Responsibilities Include

• Sitedesign, construction, start-up, and operational readiness:
• Build a team of Utilities Engineers and serve as the main point of contact for the UtilitiesEngineering function.
• Support the start-up of all site utility systems and transfer of ownership to the F&E utilities team.
• Develop and implement long term strategy for technical support of installed systems and equipment including system setups for CMMS, etc.
• Support the development and implementation of goals and objectives and associated budgets for all utility engineering services including but not limited to mechanical and HVAC systems.
• Ensure utility engineering programs are aligned with cGMP and safety requirements, local/ global regulations, and Amgen Maintenance excellence standards.
• Ensure that procedures are in place for cGMP and daily activities are followed by area personnel and contractors.
• Ensure safety of all personnel during plant construction,start-up operations, and maintenance activities across multiple shifts providing 24/7 plant and utility coverage.
• Site Operations
• Responsible for leading the Amgen NC F&E Utility Engineering staff supporting continuous clean and plant utility operations including electrical and HVAC systems at the site.
• Accountable for system ownership for Building and Process utility systems and for supplier management including:
• GMP utilities such as Plant Utilities, Purified Water (PW), Water for Injection (WFI), Clean Steam, Clean Compressed Air, and Process Gases, as well as non-GMP utilities such as waste management, electrical systems, boiler room operations, chilled water systems, plant steam, industrial gases, HVAC systems, and compressed air systems.
• Manage system ownership by providing adequate resources and technical talent and expertise, maintenance procedures, providing adequate system validation support, monitoring performance data, providing adequate training materials, and ensuring operating procedures are followed.
• Develop and support equipment maintenance programs, ensure the availability of spare parts, andcoordinating maintenance activities to ensure systems are in proper working order.
• Ensures site readiness and compliance for internal audits, external agency audits, and partner visits.
• Lead and support continuous improvement initiatives including improvements to safety, reliability, efficiency, and sustainability
• Maintain and improve utility system capability and reliability in partnership with engineering leadership and technical staff.
• Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Environmental Health & Safety, and Engineering).
• Have oversight and lead execution of complex Utilities related initiatives and projects. Provide expertise and resources for capital project execution.
• Establish clear expectations and priorities to staff. Encourage a culture of continuous improvement, partnership, and knowledge sharing. Provide development opportunities, feedback, and actively listen to staff.
• Maintain and develop key performance indicators of maintenance performance, supervise, assess, develop staff and ensure that all targets and milestones are completed on time and on budget.
• Participate in the budgeting process for Utilities, including forecasting costs, managing expenditures, and ensuring efficient allocation of resources.

Up to 10% domestic/international travel

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications

• Doctorate degree and 2 years of engineering experience
• OR
• Masters degree and 6 years of engineering experience
• OR
• Bachelors degree and 8 years of engineering experience
• OR
• Associates degree and 10 years of engineering experience
• OR
• High school diploma / GED and 12 years of engineering experience
• And
• 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• 6+ years experience in Utilityengineeringwithin the biotechnology and/or pharmaceutical or other regulatory environments.
• 3+ years experience of ensuring compliance in a highly regulated environment
• Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment
• Ability to lead multiple tasks and effectively set priorities
• Direct knowledge of GMPutilities such as Purified Water (PW), Water for Injection (WFI), Clean Steam, Clean Compressed Air, and Process Gases, as well as non-GMP utilities such as waste management, electrical systems, boiler room operations, chilled water systems, plant steam, industrial gases, HVAC systems, and compressed air systems.
• Strong knowledge of Computerized Maintenance Management Systems.
• Demonstrated skill in analyzing and improving facilities related quality systems
• Ability and willingness to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
• Strong leadership, technical writing, and communication/presentation skills.
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.

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.

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

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 toparticipatein 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.