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

Responsibilities

• 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.

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.