Clean Utilities Sr Engineer

BioSpace; Holly Springs (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

Amgen in North Carolina is seeking a Senior Utilities Engineer to own Clean and Plant Utility systems and to partner with the corporate engineering team to design, build, commission, and qualify new equipment for drug substance production. The role requires leadership, strong troubleshooting, and GMP/compliance focus across facilities operations.

You will develop maintenance programs, ensure safety and regulatory alignment, and support engineering runs, deployments, and project capital delivery

Qualifications

• Bachelor's degree in Chemical, Mechanical, or Electrical Engineering or equivalent.
• Experience in Biopharmaceutical environment and GMP facilities is preferred.
• Willingness to work 24/7 and travel domestically/internationally.

Responsibilities

• Provide system ownership for Clean and Plant Utility systems and equipment.
• Support design, construction, startup, commissioning and qualification of new or modified systems.
• Develop maintenance programs and support spare parts availability.
• Ensure safety, compliance with environmental health/safety rules, and GMP requirements.
• Lead or support root cause analysis and corrective actions to reduce downtime.

Skills

Leadership

Communication

Problem solving

Multi-tasking

Teamwork

Education

Bachelors in Chemical/Mechanical/Electrical Eng

Masters or Doctorate (preferred)

10+ years Engineering/Maintenance exp

Tools

GMP knowledge

Reliability/RC/Root Cause Analysis

Data analytics / SPC / Six Sigma

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

CLEAN UTILITIES SR. ENGINEER

What You Will Do

Lets do this. Lets change the world. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing subject matter expertise to support operations upon start up.

The Utilities System Owner reports to the Director of the Amgen North Carolina Facilities & Engineering group.

• Provide system ownership for Clean and Plant Utility systems and equipment supporting operations at the site.
• Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems.
• Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity to the equipment or facility systems. Lead the development of a business case if required to support the completion of the project.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance execution as necessary to ensure systems are in proper working order.
• Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.
• Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary.
• Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant systems.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.
• Own investigations of abnormal conditions through Deviation and business processes.

What we expect of you

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

Basic Qualifications

• High school diploma / GED and 10 years of Engineering/Maintenance experience OR
• Associates degree and 8 years of Engineering/Maintenance experience OR
• Bachelors degree and 4 years of Engineering/Maintenance experience OR
• Masters degree and 2 years of Engineering/Maintenance experience OR
• Doctorate degree

Preferred Qualifications

• Bachelors degree in Chemical, Mechanical, or Electrical Engineering
• 4+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility utility equipment/systems such as Pharmaceutical Water, Clean Steam, and Clean Air generation and distribution; and as well as other Plant Utility equipment needed to support these processes such as Chilled Water chillers, cooling towers, steam boilers, air compressors, etc.
• Experience with equipment and facility control systems operation, logic, and troubleshooting.
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• 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
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
• Understanding of the execution 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.
• Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
• Great teammate prepared to work in 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
• Ability for domestic/international travel.

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, well support your journey every step of the way.

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.

In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of 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 That May Include

• A 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
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.