Senior Manager Instrumentation and Maintenance

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 115,000 - 145,000; Full time

Job summary

Initial Therapeutics, Inc. in Holly Springs, NC is seeking a Senior Manager in Instrumentation and Maintenance to lead a team and ensure system reliability in a state-of-the-art facility. You will oversee maintenance efforts, compliance, and strategic planning alongside a collaborative team.

The ideal candidate will have extensive engineering experience, including management of teams, particularly in biotech or pharmaceutical sectors. A flexible work schedule is required to support 24/7 operations.

Qualifications

• At least 2 years of experience managing a team.
• Experience in biotechnology or pharmaceutical sectors is a plus.
• Ability to work flexible hours for 24/7 operations.

Responsibilities

• Oversee the Maintenance and Instrumentation team.
• Develop long-term support strategies for operations and maintenance.
• Ensure compliance with safety, cGMP, and regulations.

Skills

Leadership Skills

Interpersonal Skills

Technical Writing

Maintenance Management

Education

High school diploma / GED with 12 years of engineering experience OR Associate’s degree with 10 years OR Bachelor’s degree with 8 years OR Master’s degree with 6 years OR Doctorate degree with 2 years

Tools

Computerized Maintenance Management Systems

Job description

Senior Manager Instrumentation and Maintenance

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 lie within them, you’ll thrive 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 Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch 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.

What you will do

The Senior Manager Instrumentation and Maintenance will join the Facilities & Engineering (F&E) group reporting to the Facilities & Engineering (F&E) Director. In this vital role, you will oversee the Maintenance and Instrumentation team and will provide technical and administrative leadership to a large and diverse group of craft‑oriented personnel, including maintenance and instrumentation technicians. You will also provide leadership and guidance to the Maintenance and Instrumentation team supporting 24/7 operations.

Site design, construction, start‑up, and operational readiness

• Build and lead a team of Maintenance and Instrumentation professionals and serve as the main point of contact for the Maintenance function.
• Develop and implement long‑term strategy for technical support for ongoing operations and maintenance 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 maintenance services including but not limited to site maintenance and calibration programs.
• Ensure preventive maintenance and calibration 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

• Lead a team of Maintenance and Instrumentation professionals and serve as the main point of contact for the Maintenance and Instrumentation function.
• Manage maintenance related 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.
• Responsible for execution of maintenance and calibration program to support 24/7 reliability of plant operations.
• 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 plant capability and equipment 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 facilities/maintenance related initiatives and projects. Provide expertise and resources for capital project execution.
• Establish clear expectations and priorities for 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 Maintenance, 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

• High school diploma / GED and 12 years of engineering experience OR
• Associate’s degree and 10 years of engineering experience OR
• Bachelor’s degree and 8 years of engineering experience OR
• Master’s degree and 6 years of engineering experience OR
• Doctorate degree and 2 years of engineering experience

And

• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years 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

• 6+ years experience in engineering or maintenance within the biotechnology and/or pharmaceutical or other regulatory environments, or Military experience
• 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
• Strong knowledge of maintenance management and 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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we will support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Equal Opportunity Employment

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.