Sr. Director, Process Engineering & Automation (Process Controls)
Eli Lilly and Company
4 months ago
On-site
Henrico, VA
$163,500 - $239,800 USD yearly
Operations
Position Overview:
Senior Director, Process Engineering & Automation responsible for leading site process-facing engineering functions (process engineering, automation, process controls) to support startup and long-term manufacturing goals across monoclonal antibody, bioconjugates, and aseptic drug product manufacturing. Ensures process performance, equipment robustness, automation reliability, and control strategies align with product requirements, regulatory expectations, and business objectives.
Responsibilities:
Pre-Startup & Startup Phase
- Build a capable process engineering and automation organization focused on safety, quality, and operational excellence.
- Define priorities/roadmap for process engineering, automation, and process controls; develop control strategies for biologics and new modality API manufacturing.
- Contribute to site HSE/Process Safety Management, including for bioconjugate and cytotoxic compound handling.
- Serve as end user and process controls authority for process equipment (design input, automation architecture, commissioning, startup plans).
- Ensure qualified readiness of process equipment, automation systems, process controls infrastructure, utilities, and facilities for first GMP operations.
- Build technical relationships with corporate automation/process engineering teams; champion site process control initiatives.
Post-Startup Phase
- Execute and refine the process engineering/automation roadmap across mAb, bioconjugate, and aseptic drug product platforms.
- Ensure adherence to policies/standards including 21 CFR Part 11 and data integrity; manage automation governance.
- Apply industry and internal best practices in process automation, digital manufacturing, and process controls.
- Partner with Facilities Engineering on capital projects for process equipment and automation.
- Maintain qualified/safe states; ensure maintenance and change control meet highest GMP standards.
- Establish/maintain governance for process control and automation; support regulatory inspections and issue escalation.
- Develop future technical leaders for site and global roles.
Basic Requirements:
- Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related engineering discipline.
- 10+ years leading process engineering and/or automation teams in pharmaceutical/biopharmaceutical industry.
Additional Preferences:
- Experience in biologics drug substance manufacturing (mAb, bioconjugate, or aseptic drug product) with process control understanding.
- Experience with emerging modalities (ADCs; cell/gene therapy).
- Process Safety Management program implementation/management for potent/hazardous materials (bioconjugate-relevant).
- cGMP knowledge; automation standards (ISA-88, ISA-95).
- Proven relationship-building across organizational levels.
- Led complex process engineering/automation projects to GMP handover (timelines, budgets, performance).
- Developed/managed high-performing technical teams with safety/quality/continuous improvement focus.
- Experience in greenfield/major brownfield facility startups and influencing design for long-term performance/operability.
Benefits (if part of the job description):
- Anticipated wage: $163,500 - $239,800.
- Company bonus eligibility.
- Comprehensive benefits program including 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, certain time off/leave, and well-being benefits.
Application instruction:
- If you require accommodation to submit a resume, complete the accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
Senior Director, Process Engineering & Automation responsible for leading site process-facing engineering functions (process engineering, automation, process controls) to support startup and long-term manufacturing goals across monoclonal antibody, bioconjugates, and aseptic drug product manufacturing. Ensures process performance, equipment robustness, automation reliability, and control strategies align with product requirements, regulatory expectations, and business objectives.
Responsibilities:
Pre-Startup & Startup Phase
- Build a capable process engineering and automation organization focused on safety, quality, and operational excellence.
- Define priorities/roadmap for process engineering, automation, and process controls; develop control strategies for biologics and new modality API manufacturing.
- Contribute to site HSE/Process Safety Management, including for bioconjugate and cytotoxic compound handling.
- Serve as end user and process controls authority for process equipment (design input, automation architecture, commissioning, startup plans).
- Ensure qualified readiness of process equipment, automation systems, process controls infrastructure, utilities, and facilities for first GMP operations.
- Build technical relationships with corporate automation/process engineering teams; champion site process control initiatives.
Post-Startup Phase
- Execute and refine the process engineering/automation roadmap across mAb, bioconjugate, and aseptic drug product platforms.
- Ensure adherence to policies/standards including 21 CFR Part 11 and data integrity; manage automation governance.
- Apply industry and internal best practices in process automation, digital manufacturing, and process controls.
- Partner with Facilities Engineering on capital projects for process equipment and automation.
- Maintain qualified/safe states; ensure maintenance and change control meet highest GMP standards.
- Establish/maintain governance for process control and automation; support regulatory inspections and issue escalation.
- Develop future technical leaders for site and global roles.
Basic Requirements:
- Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related engineering discipline.
- 10+ years leading process engineering and/or automation teams in pharmaceutical/biopharmaceutical industry.
Additional Preferences:
- Experience in biologics drug substance manufacturing (mAb, bioconjugate, or aseptic drug product) with process control understanding.
- Experience with emerging modalities (ADCs; cell/gene therapy).
- Process Safety Management program implementation/management for potent/hazardous materials (bioconjugate-relevant).
- cGMP knowledge; automation standards (ISA-88, ISA-95).
- Proven relationship-building across organizational levels.
- Led complex process engineering/automation projects to GMP handover (timelines, budgets, performance).
- Developed/managed high-performing technical teams with safety/quality/continuous improvement focus.
- Experience in greenfield/major brownfield facility startups and influencing design for long-term performance/operability.
Benefits (if part of the job description):
- Anticipated wage: $163,500 - $239,800.
- Company bonus eligibility.
- Comprehensive benefits program including 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, certain time off/leave, and well-being benefits.
Application instruction:
- If you require accommodation to submit a resume, complete the accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.