Director, Engineering GMP/Lab Operations

TN United Kingdom; Stevenage; On-site; GBP 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Director of Engineering for GMP and Lab Operations. This pivotal role involves overseeing engineering operations, ensuring compliance, and managing a diverse team at a state-of-the-art manufacturing site. You will collaborate closely with facilities and capital projects, driving initiatives that enhance operational efficiency and regulatory compliance. The ideal candidate will have extensive experience in the pharmaceutical or biologics sectors, demonstrating exceptional leadership and communication skills. This is a unique opportunity to make a significant impact in a dynamic and innovative environment.

Qualifications

• 10+ years managing engineering in regulated environments.
• Experience in pharmaceutical, biologics, or cell/gene therapy industries.

Responsibilities

• Oversee GMP engineering at the Stevenage site.
• Manage maintenance and project engineering teams.
• Ensure compliance with cGMP and regulations.

Skills

Management of engineering operations

Leadership in pharmaceutical industry

Process engineering

GMP compliance

Vendor management

Education

BSc/BEng in Engineering

Master’s degree or MBA

Lean Six Sigma Green/Black Belt

Job description

Role Summary

The Director, Engineering GMP/ Lab Operations is responsible for engineering operations related to Autolus’ activities, including maintenance of equipment, instrumentation and calibration, asset lifecycle management, maintenance scheduling, equipment validation, process engineering, and building management systems.

Managing a diverse team, you will collaborate closely with the Director of Facilities & Capital Projects on facilities engineering and capital projects across all sites.

Key Responsibilities

Facilities

• Oversee all GMP engineering at Autolus’ Stevenage manufacturing site.
• Manage maintenance, project engineering teams, and onsite contractors, including recruitment and training.
• Ensure all facilities and equipment are operational and maintained to support production, QC labs, and warehousing.
• Maintain GMP manufacturing facilities in compliance, properly calibrated, and well-documented for audits.
• Lead teams in resolving facility issues safely and efficiently, including startup and shutdown procedures.
• Develop and implement solutions and corrective actions for maintenance issues with proper documentation.
• Collaborate with the Executive Director on establishing systems, programs, budgets, and engineering projects.
• Ensure compliance with cGMP and regulations, maintaining accurate records.
• Coordinate vendor selection and management for equipment maintenance.
• Manage multiple priorities proactively, seeking effective solutions.
• Work with EHS to ensure safety procedures and risk assessments are in place.
• Oversee engineering activities and report performance via KPIs and dashboards.
• Represent Engineering during regulatory inspections.
• Maintain stakeholder relationships and align project goals.

Additional duties as assigned by the line manager.

Skills and Competencies

Experience

• At least 10 years managing engineering operations in a regulated manufacturing environment. (E)
• Leadership experience in pharmaceutical, biologics, or cell/gene therapy industries. (P)
• Experience with instrumentation, utilities, process engineering, automation, and validation in GMP. (E)
• Managing external vendors and contractors, both remotely and onsite. (E)
• GMP experience. (E)

Qualifications

• BSc/BEng in Engineering or equivalent. (E)
• Master’s degree or MBA preferred. (P)
• Lean Six Sigma Green/Black Belt a plus. (P)

Skills/Specialist Knowledge

• Ability to lead and motivate teams in a start-up environment with ambiguity and limited resources.
• Stay current with industry trends.
• Develop relationships and influence stakeholders at all levels.
• Resolve issues constructively and operate effectively in multicultural settings.
• Lead, attract, and inspire talent and resources.
• Focus on customer-centric decisions that enhance service quality.
• Excellent communication and presentation skills across diverse cultures and organizational levels.