Director of Equipment Engineering

Director Equipment Engineering

The Director, Equipment Engineering delivers strategic and technical leadership for all equipment supporting aseptic GMP manufacturing and secondary packaging and inspection, including sterile liquid filling, lyophilization, and supporting utilities and space. This role ensures equipment is designed, qualified, maintained, and operated to meet the highest standards of sterility assurance, regulatory compliance, and supply reliability.

The position is accountable for equipment lifecycle performance, enabling robust commercial supply, successful regulatory inspections, and seamless new product introduction (NPI) in a highly controlled aseptic environment.

This role owns the full equipment lifecycle—from conceptual design and technical specification through installation, startup, commissioning (Cx), and validation support— ensuring systems are compliant, reliable, and fit for purpose.

The role serves as the primary engineering subject matter expert during regulatory inspections and audits, representing equipment design, commissioning, and validation practices. Reporting to the Sr. Director, Engineering & Maintenance, this position plays a critical role in advancing site performance, compliance, and technical strategy.

Engineering & Equipment Operations:

• Oversee day-to-day engineering and equipment activities for aseptic filling, isolators, and lyophilization equipment
• Ensure equipment reliability, preventive maintenance effectiveness, and reduced downtime
• Own lifecycle performance of equipment post-startup, ensuring sustained reliability, maintainability, and compliance
• Establish and maintain engineering standards to support long-term asset management strategy

Project Execution:

• Lead and oversee engineering projects including design, specification, installation, startup, and commissioning (Cx) of equipment systems
• Ensure robust project execution through defined turnover processes, including FAT/SAT, commissioning plans, and performance verification
• Partner with cross-functional teams to ensure seamless transition from project execution to routine operations
• Accountable for project timelines, budgets, and resource planning in alignment with site prioities

Design & Technical Oversight:

• Provide technical leadership in equipment design, selection, and specifications, ensuring alignment with process, operational, and regulatory requirements
• Ensure systems are designed for cleanability, maintainability, and compliance (cGMP)
• Oversee installation and construction activities, ensuring adherence to design intent and quality standards
• Partner with Manufacturing, Validation, and Quality to ensure system performance, operability, and compliance readiness

Compliance & Quality:

• Serve as the primary engineering representative during regulatory inspections and client audits, providing subject matter expertise on equipment design, commissioning, and validation
• Ensure inspection readiness of all engineering documentation (e.g., URS, FS/DS, FAT/SAT, commissioning and validation records)
• Owns the basis of engineering technical expertise that drives policies and procedures to achieve regulatory compliance, industry standards and best practices for producing safe, compliance and effective pharmaceutical products
• Drive timely and technically sound support for deviations, investigations, and CAPAs related to equipment and systems
• Ensure all equipment supports aseptic process control strategy, including: Contamination control (CCS alignment), Annex 1 (EU GMP) compliance, FDA aseptic processing expectations
• Partner with Quality to maintain inspection readiness (FDA, EMA,MHRA)
• Own engineering aspects of: Deviations / investigations, Change control, Media fill readiness support
• Ensure systems align with validated environmental and process controls

Team Leadership:

• Lead and develop a team of engineering professionals
• Drive a culture of ownership, safety, accountability, and continuous improvement

Vendor & Contractor Management:

• Support vendor selection, coordination, and performance management
• Ensure timely delivery of services and adherence to quality standards
• Oversee vendor execution during design, installation, and commissioning phases to ensure compliance with project and quality expectations

Commissioning, Startup & Validation:

• Lead and oversee startup and commissioning (Cx) activities, ensuring systems are installed and operate as intended
• Ensure execution of structured commissioning processes, including functional testing and equipment readiness
• Provide engineering oversight and support for validation activities (IQ/OQ/PQ) in partnership with Validation and Quality
• Ensure all turnover and validation documentation is complete, accurate, and inspection-ready