Sr. Director, Process Engineering & Automation (Process Controls)

Position Overview

The Senior Director, Process Engineering & Automation is responsible for leading the site's process-facing engineering functions — including process engineering, automation, and process controls — to ensure the team has the capacity, capability, and leadership to support site startup and long-term manufacturing goals across monoclonal antibody, bioconjugates, and aseptic drug product manufacturing operations.

Responsibilities

• Pre-Startup & Startup Phase

  • Organisational Development: Collaborate with the Site Lead Team to build a capable, inclusive, and resilient process engineering and automation organisation focused on safety, quality, and operational excellence suited to mAb, bioconjugate, and aseptic drug product manufacturing.

  • Functional Strategy: Define priorities and roadmap for process engineering, automation, and process controls. Develop systems and processes by leveraging internal expertise and external best practices, with particular emphasis on the control strategies required for biologics and new modality API manufacturing.

  • Safety Leadership: Actively contribute to the site HSE Lead Team to ensure process safety is embedded throughout project delivery and startup, including Process Safety Management considerations relevant to bioconjugate and cytotoxic compound handling.

  • Project Support: Act as end user and process controls authority for process equipment — providing input on design, automation architecture, commissioning, and startup plans to align with both project and long-term site goals across all manufacturing modalities.

  • Team Structure: Design and evolve the process engineering and automation organisation to ensure the right resources, technical leadership, and controls expertise are in place to support GMP manufacturing readiness.

  • System Readiness: Ensure qualified and safe states for process equipment, automation systems, process controls infrastructure, utilities, and facilities are established and maintained ahead of first GMP operations.

  • Corporate Alignment: Build strong technical relationships with corporate process engineering and automation teams, and champion strategic process control initiatives at the site level.

• Post-Startup Phase

  • Ongoing Strategy Execution: Continue refining and executing the process engineering and automation roadmap, aligning functional goals with site priorities across mAb, bioconjugate, and aseptic drug product platforms.

  • Compliance & Standards: Ensure adherence to corporate policies and standards across process controls, automation governance, environmental, safety, and quality domains, including 21 CFR Part 11 and data integrity requirements.

  • External Benchmarking: Maintain an outward focus to identify and apply best practices in process automation, digital manufacturing, and process controls from across the industry and Lilly's internal network.

  • Asset Management: Partner with Facilities Engineering to manage site process equipment and automation investments — planning, prioritising, and executing capital projects aligned with site objectives and manufacturing lifecycle requirements.

  • Operational Integrity: Ensure process equipment and control systems remain in a qualified and safe state, and that all process-related maintenance and change control activities are performed and documented to the highest GMP standards.

  • Governance & Controls: Establish and maintain robust process control and automation governance systems to manage compliance, support regulatory inspections, and escalate issues appropriately.

  • Leadership Development: Cultivate future process engineering, automation, and controls leaders for the site and potential global roles within Lilly's manufacturing network.

Basic Requirements

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, or a related engineering discipline
• 10+ years of experience in a leadership role managing process engineering and/or automation teams within the pharmaceutical or biopharmaceutical industry

Additional Preferences

• Experience in biologics drug substance manufacturing, including monoclonal antibody, bioconjugate, or aseptic drug product processes, with a strong understanding of associated process control requirements.
• Familiarity with new and emerging modalities, including ADCs and cell or gene therapy platforms, and the unique process engineering challenges they present.
• Experience in the implementation and management of Process Safety Management programmes, particularly in environments involving potent or hazardous materials relevant to bioconjugate manufacturing.
• Strong understanding of cGMPs, automation standards (including ISA-88, ISA-95), and their application to biologics manufacturing operations.
• Proven ability to build effective relationships across all organisational levels — from site leadership to frontline engineering and automation teams.
• Demonstrated success in leading complex process engineering and automation projects from initiation through to GMP manufacturing handover, meeting timelines, budgets, and performance standards.
• Track record of developing and managing high-performing, engaged technical teams with a strong focus on safety, quality, and continuous improvement culture.
• Experience contributing to or leading greenfield or major brownfield facility startups, with the ability to influence design decisions that optimise long-term process performance and operability.