Career Category

Job Description

Role Description

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

The Utilities engineer will be responsible for ensuring the facility, equipment and systems are constructed in accordance with the detailed design and that GMP qualification is achieved and complied. This will also include ensuring the design meets the requirements of Manufacturing, Quality, Information Systems, and Engineering groups.

This position will interface with the design team, construction management firm, equipment vendors, system integrators, and the commissioning agent as part of the project execution team. Another key role will be interfacing with Amgen’s Corporate Engineering Subject Matter Experts (SME).

Engineer shall interface with external vendor to ensure delivery of highest service level of performance in accordance with contractual requirements. The Engineer will be the Subject Matter Expert (SME) for the Utilities system operations, maintenance and provide technical/expertise support to site’s during the project phase from construction, commissioning, qualification phase and also ensures readiness for routine operations.

Engineer shall ensure adherence to standards and good engineering practices. Ensure designs optimize the total life cycle cost of the asset. Lead resolution of complex technical issues and conflicts. Support development of commissioning and qualification documents to ensure the utilities system is qualified per regulatory requirement.  Independently resolve technical issues, escalate problems, work in teams, and promote sharing of lessons learned. 

Responsibilities

General

• Leverage technical expertise to ensure project success.
• Communicate effectively across multi-functional teams across the company (remote or otherwise). 
• Supervise, coordinate and review work of other team members or third-party resources on an ongoing basis as well as on a project basis.

Project Engineering

• Participate in the system walkdown, ensure the closing of punch items and support the takeover of the systems from the Project team
• Interface with Commissioning team to support the commissioning of all Utilities system.

System Owner and Ongoing Production Support

• Primary role as SME in Utilities system
• Lead deviation investigation and ensure Corrective and Preventive Action (CAPA) is in place to prevent recurrence of similar incident.
• Drive the Continuous improvement of Utilities system operating, maintenance and reliability program.
• Support and coordinate qualification/validation activities as the owner of the system.
• Key interface with the external vendor to ensure that all the Utilities system maintenance are in compliance with cGMP quality and regulatory requirements.
• As the Subject Matter Expert (SME), provides technical and compliance support related to Utilities Equipment system.
• Provide support to the development, revision, review, and approval of Standard Operating Procedures, Risk Assessment, Preventive maintenance program and Job Plans.
• Systems engineering audit to ensure compliance to all relevant site SOPs, global SOPs, GEP and GDP.
• Establish metrics that ensure optimal utility operational performance. 

Basic Qualifications

• Master’s degree in Engineering OR
• Bachelor’s degree in Engineering and 2 years of directly related experience OR
• Associate’s degree in Engineering and/or 6 years of directly related experience OR
• High school diploma in Engineering / GED and 8 years of directly related experience

Preferred Qualifications

• At least 3 years of engineering, operations and maintenance Utilities system in the pharmaceutical/Biologicals manufacturing processes.
• Proven experience working in GMP environment
• Familiarity with documentation in a highly regulated environment
• Familiarity with computer validation processes and software testing techniques
• Engineering documentation expertise (e.g., P&IDs, User requirement specifications, functional specifications, design specifications and protocols)
• Proficient with relevant industry standards (e.g. ASTM E2500, 21 CFR Part 11, USP etc.)
• Problem solving skills and ability to influence
• Fluency in English, in both oral and written communications
• Project Management Skills
  • Experience managing contractors and vendors