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 / GED and 8 years of directly related experience
• Ability to work proactively, independently and collaboratively
• Good interpersonal and communication skills with high computer literacy
• Strong team player, able to effectively work within and across teams
• Preferred at least 2 years of engineering, operations maintenance Utilities system in the pharmaceutical/Biologicals manufacturing processes or equivalent experiences.
• Proven experience working in GMP environment
• Knowledge on CMMS, BMS, QEMS, DeltaV
• 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 understanding with relevant industry standards (e.g. ASTM E2500, 21 CFR Part 11, USP, ISO14644, etc.)
• Strong analytical skills for problem solving and also to identify potential improvement opportunities.
• Project Management Skills leading contractors and vendors.
• Interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met in compliance and safe manner.
• Ability to thoughtfully negotiate and positively influence peers.
• Ability to provide On-Call support coverage on weekends
• Flexibility to work off-hour

A core part of this job is supporting site sustainability goals by implementing energy efficiency improvements, water conservation measures, and other environmental best practices within the utilities’ scope. The engineer will independently solve technical challenges, call out matters when needed, work collaboratively across departments, and promote knowledge sharing to drive ongoing improvement and sustainable results.

• Primary responsibilities include acting as the System Owner and Subject Matter Expert (SME) for Clean (Purified Water, WFI, Clean Steam, Caustic Dilution System, Process Gases, etc.) and/or Black (Chilled Water, Steam, Compressed Air, Cooling Tower, Waste, HVAC, Downflow booth, BSC, Hood, CTC etc.) Utilities Equipment and Systems.
• Provide technical expertise to ensure safe and compliant system operation, hands-on support for process or equipment issues, monitoring and analyzing system performance.
• Collaborate with multi-functional teams to support production, quality, compliance, safety and regulatory activities and requirements.
• Communicate effectively across multi-functional teams across the company (remote or otherwise).
• Partnership with Maintenance & Utilities operation team to ensure alignment on maintenance, operation, and system improvement plans
• Lead/own deviation investigation and ensure Corrective and Preventive Action (CAPA) is in place to prevent recurrence of similar incident.
• Develop and oversee equipment maintenance program and alignment with compliance to standard, regulatory and network practices.
• Provide support the development, periodic revision, review, and approval of Standard Operating Procedures, Risk Assessment, Preventive maintenance program and Job Plans.
• Supervise, coordinate and review work of other team members or third-party resources on an ongoing basis as well as on a project basis.
• Drive or support the Continuous improvement of Utilities system operating, maintenance and reliability program.
• Establish metrics to monitor, measure and ensure optimal utility operational performance.
• Participate in and front internal and external regulatory audits
• Serve as a key point of contact with the external vendor to ensure that all the Utilities system maintenance are in compliance with cGMP quality and regulatory requirements.
• Conduct systems engineering audits to ensure compliance to all relevant site SOPs, global SOPs, GEP and GDP.
• Participate in project as system SME to provide recommendations on technical, safety and compliance aspect as applicable to ensure project success.
• Participate in the system walkdown, ensure the closure of punch items and support the takeover of the systems from the Project team.
• Collaborate with Commissioning team to support the commissioning of all Utilities system.
• Support and coordinate qualification and validation activities as the owner of the system.
• Support Site Sustainability program - Analyze Energy consumption data, benchmark the overall usage/consumption, and evaluate opportunities to optimize its usage.
• Support the development of business case to drive the site goal on sustainability targets.
• Prepare utilities consumption data for submissions to authorities.
• All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities

WHAT YOU WILL DO

In this vital role, the Engineer (Utility) reporting to the Engineering, Manager (Utility), is responsible for ensuring that the utilities equipment and systems are designed, operated, and maintained according to detailed design specifications, operational needs, and Good Manufacturing Practice (GMP) standards. This will also include ensuring the system meets the requirements of quality, safety, engineering, regulatory and industrial standards.
This position will collaborate with multi-functional teams to gather and document system requirements, perform system testing, solve issues, provide cross multi-functional support including project execution team. Another key role will be collaborating with Amgen’s Corporate Engineering Subject Matter Experts (SME).
As the Subject Matter Expert (SME) for utility system operations and maintenance, the Utilities Engineer offers vital technical expertise throughout construction, commissioning, qualification, and regular operation phases. The engineer will liaise with external vendors to confirm that services meet contractual and quality standards. Engineer shall ensure consistency to established engineering practices and standards while actively seeking ways to optimize asset life cycle costs. The Utilities Engineer will tackle complex technical issues, help develop commissioning and qualification documents and maintain regulatory compliance for utility systems.

A core part of this job is supporting site sustainability goals by implementing energy efficiency improvements, water conservation measures, and other environmental best practices within the utilities’ scope. The engineer will independently solve technical challenges, call out matters when needed, work collaboratively across departments, and promote knowledge sharing to drive ongoing improvement and sustainable results.

• Primary responsibilities include acting as the System Owner and Subject Matter Expert (SME) for Clean (Purified Water, WFI, Clean Steam, Caustic Dilution System, Process Gases, etc.) and/or Black (Chilled Water, Steam, Compressed Air, Cooling Tower, Waste, HVAC, Downflow booth, BSC, Hood, CTC etc.) Utilities Equipment and Systems.
• Provide technical expertise to ensure safe and compliant system operation, hands-on support for process or equipment issues, monitoring and analyzing system performance.
• Collaborate with multi-functional teams to support production, quality, compliance, safety and regulatory activities and requirements.
• Communicate effectively across multi-functional teams across the company (remote or otherwise).
• Partnership with Maintenance & Utilities operation team to ensure alignment on maintenance, operation, and system improvement plans
• Lead/own deviation investigation and ensure Corrective and Preventive Action (CAPA) is in place to prevent recurrence of similar incident.
• Develop and oversee equipment maintenance program and alignment with compliance to standard, regulatory and network practices.
• Provide support the development, periodic revision, review, and approval of Standard Operating Procedures, Risk Assessment, Preventive maintenance program and Job Plans.
• Supervise, coordinate and review work of other team members or third-party resources on an ongoing basis as well as on a project basis.
• Drive or support the Continuous improvement of Utilities system operating, maintenance and reliability program.
• Establish metrics to monitor, measure and ensure optimal utility operational performance.
• Participate in and front internal and external regulatory audits
• Serve as a key point of contact with the external vendor to ensure that all the Utilities system maintenance are in compliance with cGMP quality and regulatory requirements.
• Conduct systems engineering audits to ensure compliance to all relevant site SOPs, global SOPs, GEP and GDP.
• Participate in project as system SME to provide recommendations on technical, safety and compliance aspect as applicable to ensure project success.
• Participate in the system walkdown, ensure the closure of punch items and support the takeover of the systems from the Project team.
• Collaborate with Commissioning team to support the commissioning of all Utilities system.
• Support and coordinate qualification and validation activities as the owner of the system.
• Support Site Sustainability program - Analyze Energy consumption data, benchmark the overall usage/consumption, and evaluate opportunities to optimize its usage.
• Support the development of business case to drive the site goal on sustainability targets.
• Prepare utilities consumption data for submissions to authorities.
• All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.