Engineer (Calibration)
Career Category
EngineeringJob 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.
Engineer I (Calibration)
What you will do
Let’s do this. Let’s change the world. In this vital role you will serve as a front-line technical resource, providing technical support and leadership within assigned systems, equipment and workstreams. The role is expected to be actively present at the equipment to support maintenance execution, troubleshoot breakdowns, verify work quality, coach technicians, and ensure safe, compliant, and right-first-time maintenance practices in a GMP manufacturing environment. The Engineer will provide practical technical leadership for electrical, calibration, instrumentation, analytical equipment, utilities, and maintenance execution, with strong focus on equipment reliability, troubleshooting, field decision-making, and rapid issue resolution. The role will partner closely with Manufacturing, Maintenance, Engineering, Quality, EHS, Planning and Scheduling, System Owners, contractors, and vendors to support production needs, strengthen preventive maintenance effectiveness, resolve deviations and non-conformances, and drive continuous improvement through lessons learned from actual field execution.
General (Instrumentation)
Support the implementation, maintenance and continuous improvement of the site calibration strategy and act as the technical point of contact for assigned systems, equipment or program elements.
Serve as a technical point of contact for assigned calibration, instrumentation and analytical-equipment activities and, where designated, as the primary technical contact for defined systems or workstreams.
Develop, review and approve calibration data sheets for assigned projects, systems and equipment, in accordance with delegated authority and approved CMMS and calibration-program requirements.
Conducts regular assessments of metrology systems, standards, instruments, and equipment to ensure accuracy and precision in measurement, adhering to corporate calibration program.
Participate in any Supplier Audit to incorporate as “Approved Calibration Supplier” as part of a Calibration Program.
Equipment/Process Equipment knowledge to perform sophisticated solving of equipment failures or malfunctions and/or the development of technical assessments.
Coordinate activities and provide technical guidance, coaching and work-quality review to technicians, engineers and contractors, without direct people-management accountability.
Execution of Installation/Operation/Performance qualification
Lead routine or clearly defined investigations related to non-conformances and deviations, including development of technical inputs for CAPA and change control; support or lead more complex investigations, CAPA actions, and change controls as assigned.
Demonstrate project management skills, application of concepts and apply knowledge of engineering principles and practices outside of area of field expertise to broad variety of assignments in related fields.
General (Electrical)
Managing 230V/400V small power DBs, UPS, gensets, and Ex-rated equipment.
Leading and supporting electrical switch gear maintenance, troubleshooting, and RCA documentation.
Supporting predictive maintenance and small CapEx projects.
Ensuring regulatory compliance (e.g., NEA, EnMS, GHG, EUR) and energy reporting
Field Technical Leadership & Execution Support
Identify cost, reliability, and resource optimization opportunities through regular shopfloor engagement, review of maintenance execution, and discussions with key stakeholders; engage the global network only to share and adopt relevant best practices, without broader network accountability.
Build technician capability by providing practical technical guidance, hands-on coaching during field execution, and role-modeling strong safety, GMP, and maintenance practices.
As a member of the GMP F&E extended leadership team, partner with maintenance managers to improve instrumentation support.
Triage and resolve issues related to electrical or instrumentation process deviation and non-conformances.
Provide visible shopfloor technical support during maintenance execution, equipment breakdowns, troubleshooting, start-up, shutdown, and post-maintenance verification activities.
Work directly with technicians and contractors at the equipment to diagnose issues, verify maintenance quality, coach correct work practices, and reinforce GMP and safety expectations.
Regularly review work execution in the field to identify technical gaps, recurring equipment issues, job plan improvement opportunities, and training needs.
Support urgent production and utility issues by providing practical, science-based troubleshooting guidance and timely escalation where required.
Develop and sustain practical, field-based technical training and qualification roadmaps for maintenance personnel in calibration and electrical disciplines, using actual equipment issues, job observations, troubleshooting cases, and hands-on coaching to build technician capability.
Capture and share practical field knowledge from calibration, instrumentation, and electrical maintenance activities, including troubleshooting guides, lessons learned, best practices, technical standards, and training materials that support knowledge retention and technician capability development.
Assess technician technical proficiency through field observations, practical assessments, and coaching engagements, identifying gaps and development opportunities.
Provide field-based technical oversight of maintenance service providers and contractors during maintenance execution, ensuring work quality, compliance with engineering standards, safe GMP practices, and effective transfer of technical knowledge to site personnel.
Provide technical input to technician qualification and contractor-performance assessments, while the accountable manager or contract owner retains formal performance accountability.
Technical
Provide technical expertise to support the established calibration program and, where designated, serve as SME for assigned systems, equipment or defined program elements.
Knowledge of regulatory requirement for pharmaceutical instrumentation application and analytical equipment. (USP857, USP645, ISO17025 etc.)
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Master’s degree OR
Bachelor’s degree and 2 years of directly related experience OR
Associate’s degree and/or 4 years of directly related experience OR
High school diploma / GED and 6 years of directly related experience
Experience in leading various collaborators’ expectations.
Good interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met.
Strong technical knowledge of utilities, mechanical maintenance, maintenance execution, and equipment troubleshooting in a GMP manufacturing environment.
Ability to provide technical oversight, influence maintenance execution, and guide technicians and contractors without direct people-management accountability.
Strong communication and interpersonal skills, with the ability to work effectively with Manufacturing, Maintenance, Engineering, Quality, EHS, Planning and Scheduling, System Owners, contractors, and vendors.
Strong analytical and science-based problem-solving skills, with demonstrated ability to support troubleshooting, Root Cause Analysis, CAPA implementation, and continuous improvement.
Proven experience working in a GMP environment with strong awareness of safety, compliance, documentation, and maintenance quality requirements.
Experience managing contractors, vendors, and third-party service providers for routine, non-routine, and improvement maintenance activities.
Experience with CMMS work order management, preventive maintenance, job plan improvement, maintenance procedures, and schedule coordination preferred.
Experience developing or supporting technical training frameworks, qualification programs, technician competency assessments, knowledge repositories, or contractor technical governance programs preferred.
Ability to communicate complex technical ideas in a clear, practical manner that non-engineering stakeholders can understand and apply.
Knowledge in the use of digital and analytical tools such as Excel, Power BI, Tableau, Smartsheet, Spotfire, or similar tools preferred.
Team player with a can-do attitude, continuous improvement mindset, and desire to make a difference.
Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.
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’ll 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.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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.
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