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 production of Active Pharmaceutical Ingredient (API) molecules located in Lebanon, Indiana, USA. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the team for the startup of a greenfield 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.
Overview:
The Associate Director – Process Control & Automation Engineering is responsible for the supervision of the process control engineers and technicians that support the daily operations of the facility. The Associate Director is also responsible for the productivity and development of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing of API (active pharmaceutical ingredient) / drug substance. Additionally, the Associate Director partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives.
The successful candidate will drive the evolution of automation infrastructure toward Industry 4.0 standards, champion GMP compliance and data integrity, and lead cross-functional teams to deliver engineering excellence across DCS, PLC, SCADA, batch automation, and HVAC/utilities platforms.
In the project delivery phase and startup phase the leadership roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. During delivery, this role will collaborate with A&E firms, system integrators, and corporate and site engineering peers. Post-project delivery, this role will support GMP manufacturing operations in the central engineering function supporting one or more process teams.
Key Objectives/Responsibilities:
Pre-Startup and Startup Phase:
- Attract, hire, and onboard top talent to the Process Control & Automation Engineering team, establishing the right attitude, curiosity, and learning agility to deliver on the site mission.
- Build the organization with the necessary capability, capacity, and culture to operate this facility to the highest standards of safety, quality, and operational excellence.
- Develop and implement the business systems and processes needed to run the site, leveraging existing Lilly knowledge where necessary, but also incorporating external experience.
- Establish lean practices and a continuous improvement mindset throughout operations and the direct supporting organizations.
- Support the project team to deliver the facility by providing feedback and support on design decisions, commissioning & qualification strategies, and automation-related deliverables.
- Collaborate with the project team to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.
- Organize and implement strategy for creating standard automation and process control operating procedures (SOPs) for startup and post-startup phases.
- Plan and manage business operational expenses, capital, and headcount targets.
Post-Startup:
- Supervise and coach process control team, including completing performance reviews and development plans.
- Staffing, including recruiting, resource planning, and succession planning.
- Process control work coordination.
- Review and monitor financial performance; commit to meeting targets.
- Develop and implement the Process Control Engineering Business Plan.
- Demonstrate a commitment to environmental, health, and safety (including PSM).
- Identify, track, and report key indicators of functional performance.
- Ensure team is operating in a state of compliance.
- In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.
- Assure focus by engineers and completion of critical assignments with appropriate monitoring and reporting.
- Review and approve automation-related deviations and change controls.
- Review and approve automation and process control standard operating procedures (SOPs).
- Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, validations, procedures, and control strategies.
- Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits.
- Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.
- Develop future management and technical expert leadership for the site.
Operational Excellence
- Demonstrate a commitment to environmental, health, and safety (including PSM)
- Identify, track, and report key indicators of functional performance.
- Ensure team is operating in a state of compliance.
Organizational Capability
- In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.
- Assure focus by engineers and completion of critical assignments with appropriate monitoring and reporting.
- Be a fully active member of the flow leadership in running the plant, including participation on management sub-teams.
Basic Qualifications:
- Minimum Bachelor’s degree in Engineering, Chemical or Electrical preferred, Instrumentation & Control, or a closely related technical discipline.
- 10+ years of experience in Process Control & Automation Engineering related field, preferably in a regulated GMP pharmaceutical manufacturing environment.
- 3+ years of related leadership experience in Process Control and Automation Engineering.
Additional Skills/Preferences:
- Experience in API manufacturing.
- Experience with automation platforms including Emerson DeltaV, Rockwell Automation, and AVEVA PI Historian.
- Experience with enterprise automation standardization and digital manufacturing initiatives.
- Working experience with Industrial Utilities Automation Systems including:
- Steam Generation and Distribution
- Nitrogen Generation and Distribution
- Compressed Air (Instrument and Process)
- Chill Water Generation and Distribution
- Potable Water Distribution and Process Water Generation and Distribution
- Working experience with Automated Tank Farm Operations.
- Ability to instill teamwork within the department and demonstrate key interpersonal skills.
- Ability to ensure appropriate technical depth and rigor with departmental technical deliverables.
- Successful application of organizational models through recruiting and retention of employees.
- Ability to make decisions independently and to network with others as appropriate.
- Ability to function in a team environment as a leader and as a member of management teams.
- State licensure as a Professional Engineer is not required but is preferred.
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
$123,000 - $180,400
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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