Director of Engineering

Role Summary

The Director of Engineering for GMP/Lab Operations is responsible for overseeing engineering operations, including equipment maintenance, calibration, asset lifecycle management, process engineering, and facility systems. The role ensures the smooth running of engineering activities across all sites, supporting production, QC laboratories, and warehousing. You will also work closely with the Director of Facilities and Capital Projects for any facility engineering or capital project needs. Managing a diverse team, you will lead efforts to maintain compliance and ensure operational excellence.

Key Responsibilities

Facilities

• Oversight of all GMP engineering at the company\’s primary manufacturing site.
• People management of maintenance and project engineering teams, as well as contractor staff. Responsibilities include recruitment, training, and team development.
• Ensure all facilities and equipment are operational to support production, QC laboratory, and warehouse activities across all sites.
• Ensure cGMP manufacturing facilities are maintained, calibrated, and documented to meet regulatory standards and are audit-ready.
• Lead teams to quickly resolve facility support system issues and safely manage start-up and shutdown processes.
• Recommend solutions and implement corrective actions for complex maintenance issues using industry-standard documentation practices.
• Collaborate with the Executive team to establish GMP engineering programs, optimize processes, and manage operational budgets.
• Ensure compliance with cGMP regulations and other governmental standards for maintenance and calibration activities.
• Drive vendor selection and management for equipment maintenance and services, collaborating with Procurement.
• Manage multiple priorities, often conflicting, with transparency and creativity to resolve challenges effectively.
• Work with the Environmental Health and Safety team to ensure appropriate site procedures, risk assessments, and safety protocols are in place.
• Provide oversight for engineering activities and report performance through KPIs and dashboards to senior management.
• Represent engineering during regulatory inspections.
• Ensure clear communication and effective stakeholder management to align project goals with expectations.

Skills and Competencies

Essential (E)

Preferred (P)

Experience

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

Qualifications

• BSc/BEng in Engineering or a related field, or equivalent experience. (E)
• Master\’s degree or MBA. (P)
• Green Belt or Black Belt in Lean Six Sigma is a plus. (P)

Skills/Specialist Knowledge

• Start-up culture – Ability to lead and motivate a team in a fast-paced environment with lean resources. Hands-on leadership, adaptability, and multitasking are key.
• Industry awareness – Stays current with business trends and innovations.
• Influence – Skilled at building relationships and influencing decision-makers at all levels within a matrixed organization.
• Interpersonal effectiveness – Resolves conflicts constructively and operates effectively in a multicultural work environment.
• Leadership – Proven ability to attract, lead, and inspire teams across the organization.
• Customer-centricity – Considers customer impact in all decisions, ensuring any changes improve service.
• Communication – Excellent interpersonal and presentation skills, with the ability to effectively communicate across all organizational levels and cultures.