Sr. Principal Engineer- Utilities

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, and bioconjugates in Goochland County, Virginia. This facility is intended to provide capacity for current and future products.  This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

The Utilities Engineer is responsible for establishing and maintaining reliable operation and qualified state of clean utility systems and supporting grey systems that support Biotech manufacturing. The Utilities Engineer will ensure that processes are in-control, compliant, and capable of meeting manufacturing needs, while also driving continuous improvement.

Key Responsibilities:

Ensure a safe working environment by following safety rules and helping improve the safety culture.

Provide clean system engineering expertise as an active member of area team.

Clean system unit operations and equipment are maintained and are in a qualified and reliable state.

Establish and/or monitor the critical parameters for all clean systems to ensure that these are in control.

Lead Troubleshooting efforts to resolve difficult unit operations, equipment and operational issues.

Evaluate all activities for impact on qualified state of equipment and utilize appropriate tools as necessary.

Supporting the grey utility

Facility Start-Up: 

Provide engineering support to the Global Facility Delivery Team (Lilly’s global large scale capital delivery team) with a strong focus on right first time and on-schedule facility start-up. This includes design reviews, process safety assessments, user requirements, C&Q support, unit operation shakedown and start-up, facility operational readiness.

Define and own relevant aspects of the overall integrated operational readiness plan (e.g. SOP development, maintenance strategy, automation optimization, pre-startup safety reviews, alarm requirements, performance qualification requirements/protocol development, etc.)

Own the qualified state of equipment for respective area of responsibility

Develop and implement unit operation and equipment control strategy to sustain and optimize utilities systems in support of manufacturing operations

Support initial operations training requirements as the equipment and area SME

Safety:

Take responsibility for the safe design and safe operation of the equipment within the area.

Actively participate in safety-related activities (audits, hazard reviews, pre-start up safety reviews) to drive ongoing safety improvement.

Bio-process Technical Support:

Be the point of contact and be the technical expert for equipment and processes in area of responsibility. This includes clear understanding of unit operations and associated equipment operations.

Monitor the utility systems and optimize the unit operations and equipment performance.

Lead troubleshooting efforts relating to unit operations, equipment and operational issues.

Utilize formal problem-solving techniques, including Root Cause Analysis, to resolve unit operations and equipment issues.

Respond to unit operations issues and equipment failures, document appropriately and ensure resolution of events through appropriate actions.

Communicate effectively with others, especially team members, operations and crafts personnel.

Maintain Qualified and Reliable State:

Evaluate all activities for impact on qualified state of unit operations/equipment and utilize appropriate business processes as necessary (change control etc).

Responsible for system/component classification and maintenance strategy for equipment.

Implement corrections, corrective actions, and countermeasures arising from investigations.

Participate in Periodic Reviews for systems and equipment.

Lead IQ/OQ/PQ activities (including commissioning activities of new unit operations/equipment)

Asset Management:

Develop scope for capital projects targeted at both short- and longer-term needs. Act as user representative for local projects.

Understand equipment reliability issues with the objective of improvement.

Aid the coaching of operators and maintenance technicians in the effective use of equipment

Improve Business:

Identify and drive improvement opportunities (procedural changes, upgrades, projects etc) associated with unit operations/equipment within the area.

Basic Minimum Qualifications:

Bachelor’s Degree required. Degree in Engineering or related technical field preferred.

Minimum of 5 years’ experience in Utility Engineering Teams, preferably in a manufacturing GMP environment.

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences:

Ability to build and maintain strong relationships with site stakeholders including site lead team, production, quality, safety and global engineering groups.

Travel up to 10%. At times will travel offsite to other Lilly locations, other companies, conferences, off-site training or to support capital projects.

Knowledge of one or more of the following areas; Clean Utilities, Black Utilities, HVAC, Electrical.

Excellent communication skills

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$66,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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