Clean Utilities Engineer
Amgen Inc. (IR)
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Benefits offered by this job
Job summary
Amgen Inc. in North Carolina seeks a Clean Utilities Engineer to provide daily engineering support at the site. You will own utility systems, lead design, startup, commissioning and qualification activities, and drive improvements to reduce downtime.
The role requires strong knowledge of GMP, safety practices, and cross-functional teamwork with manufacturing, maintenance, QA, and validation. Occasional on-call coverage and after-hours support are expected.
Qualifications
- High school diploma / GED and 8 years of Engineering/Maintenance experience.
- Associate’s degree and 6 years of Engineering/Maintenance experience.
- Bachelor’s degree and 2 years of Engineering/Maintenance experience.
- Master’s degree
Responsibilities
- Provide system ownership for 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/instrument maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper order.
- Ensure systems are installed and operating safely 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.
- Develop, coordinate, analyze, and present results for operational issues and engineering projects.
- Provide technical support to commercial and clinical manufacturing as needed, specifically to process control and process equipment.
- Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements.
- Communicating with supervisor and support staff, highlighting issues and proposing solutions.
- Work in a small group of engineers and/or technicians on an ongoing or project basis.
- Provide technical support and issue resolution with 24x7 on-call support of Utility systems on a rotational based frequency (Support may be required outside of normal working hours including nights, weekends, and holidays).
- Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable components.
- Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, throughput, or other unique capabilities to Amgen manufacturing.
Skills
Education
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. 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, 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.
Let’s do this. Let’s change the world. In this vital role you will report to the Senior Manager of the Process Engineering group. The position is responsible for providing daily Engineering support at the Amgen North Carolina site.
- Provide system ownership for 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/instrument maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper order.
- Ensure systems are installed and operating safely 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.
- Develop, coordinate, analyze, and present results for operational issues and engineering projects.
- Provide technical support to commercial and clinical manufacturing as needed, specifically to process control and process equipment.
- Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements.
- Communicating with supervisor and support staff, highlighting issues and proposing solutions.
- Work in a small group of engineers and/or technicians on an ongoing or project basis.
- Provide technical support and issue resolution with 24x7 on-call support of Utility systems on a rotational based frequency (Support may be required outside of normal working hours including nights, weekends, and holidays).
- Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable components.
- Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, throughput, or other unique capabilities to Amgen manufacturing.
We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek is a dynamic, flexible, and driven individual with these qualifications.
- High school diploma / GED and 8 years of Engineering/Maintenance experience
- Associate’s degree and 6 years of Engineering/Maintenance experience
- Bachelor’s degree and 2 years of Engineering/Maintenance experience
- Master’s degree
- Bachelor’s degree in chemical or mechanical engineering
- 2+ 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, Clean Air generation and distribution, and CIP; 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.
- 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
- Strong leadership, technical writing, communication/presentation skills and the ability to work with minimum direction.
- Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.
- Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.
- Ability to function within cross-functional teams and embrace a team-based environment.
- 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 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 teammates prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
- Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.
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.
Salary Range 88,281.00USD -119,439.00 USD
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.
Sponsorship for this role is not guaranteed.
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.
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.
Refer to the Work Location Type in the job posting to see if this applies.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen
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