Job Description & How to Apply Below
Location: Henrico
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
_Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing 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._
** 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. This role provides both administrative and technical leadership for process engineering and automation operations, with a particular focus on establishing robust process control strategies and automation frameworks suited to biologics and advanced modality manufacturing.
The Senior Director is accountable for ensuring that process performance, equipment robustness, automation reliability, and control strategies are aligned with product requirements, regulatory expectations, and business objectives.
As a member of the Lilly Site Lead Team, the Senior Director contributes to shaping the site's strategic direction, building organisational capability, and managing cross-functional issues. The team works collectively to achieve long-term business objectives, adapt to evolving corporate and external environments, and develop the site for future success.
During the project delivery and startup phase, the Site Lead Team will operate dynamically to support project execution, build the organisation, implement GMP systems and processes, and establish site culture. This will require strong collaboration, creativity, and resilience across a highly complex and technically demanding manufacturing environment.
** Responsibilities*
* ** Pre-Startup & Startup Phase*
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** 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.
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** 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.
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** 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.
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** 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.
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** 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.
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** 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.
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** 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*
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** 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.
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** Compliance & Standards:
** Ensure adherence to corporate policies and standards across process controls, automation governance, environmental, safety, and quality domains, including 21 CFR Part 11…
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