Director, Facilities and Engineering

Mantell Associates is partnered with a global CDMO, who are searching for a Director, Facilities and Engineering to join their organisation in Boston, MA. Reporting to the Operations Head, North America, you will lead a multidisciplinary organisation covering facilities operations, maintenance, process engineering, metrology/calibration, commissioning/qualification/validation (CQV), automation, and CAPEX deployment.

The role ensures uninterrupted operation of GMP plant systems; timely maintenance, calibration, and certification of equipment and facilities; reliable performance of automation and computerised systems; and compliant CQV execution. You will be responsible for delivering facility, utility, metrology, automation, and infrastructure modifications in line with GMP, data integrity, cybersecurity, and operational excellence requirements. You will also support CAPEX deployment, resourcing, and cGMP engineering oversight for new construction projects at the company’s second Massachusetts facility.

Director, Facilities and Engineering - Responsibilities:

• Develop and implement strategy for Facilities, Engineering, Maintenance, Metrology, CQV, Automation, Process Engineering, and site IT/OT to support operational reliability, compliance, and business objectives
• Own and continuously improve preventive maintenance, calibration/metrology, CQV, automation, computerised systems, and cGMP engineering documentation programmes
• Ensure uninterrupted, compliant operation of GMP equipment, facilities, utilities, and automation systems, resolving issues promptly to minimise downtime
• Oversee CQV for new equipment, facility expansions, process changes, and automation systems, maintaining the site’s validated state through periodic review and requalification
• Lead automation, computerised system, and IT/OT initiatives, including upgrades, integrations, data integrity, cybersecurity, backup/recovery, and lifecycle management
• Plan, prioritise, and execute capital projects (CAPEX), defining design requirements and approving purchases of equipment, systems, and services
• Ensure the site is commercially ready and inspection-ready, representing engineering in regulatory inspections, pre-approval inspections, and partner audits, and owning responses to engineering-related observations
• Drive change controls for equipment, facility, utility, automation, and IT changes through the quality system, supporting deviations, investigations, and CAPAs with sound engineering root-cause analysis
• Monitor evolving regulatory expectations and industry trends (e.g. FDA, EU GMP Annex 1 and Annex 11, 21 CFR Part 11, data integrity, cybersecurity) and update site programmes accordingly
• Support engineering CAPEX projects at the second site by deploying resources, hiring talent, and making key cGMP engineering decisions
• Collaborate with Process Development, Manufacturing, Quality, and Supply Chain, and direct contractors, integrators, and vendors to approved specifications

Wider Leadership Responsibilities:

• Build, lead, and develop a high-performing multidisciplinary organisation across both sites, including recruitment, coaching, performance management, and succession planning
• Establish departmental strategy, goals, and KPIs aligned with company priorities and growth
• Manage operating and capital budgets, allocating staff, contractor, and financial resources across all reporting functions
• Partner with HR and senior leadership to assess organisational structure, capability gaps, and staffing needs for current operations and multi-site growth
• Foster a culture of safety, cGMP compliance, data integrity, cybersecurity, and continuous improvement

Director, Facilities and Engineering - Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline; Master’s degree in Engineering, a technical discipline, Operations Management, or an MBA preferred
• 7+ years of progressive leadership experience within a GMP-regulated manufacturing environment, preferably biotechnology, pharmaceutical, or life sciences
• Demonstrated experience leading Facilities, Engineering, Maintenance, Metrology, CQV, Automation, and/or IT functions within a regulated environment
• Strong cross-functional leadership experience, with the ability to collaborate with and influence stakeholders across Manufacturing, Quality, Process Development, Supply Chain, Validation, Regulatory, and Executive Leadership
• Proven experience managing capital projects, facility expansions, infrastructure upgrades, and operational improvement initiatives
• Experience managing departmental operating and capital budgets, strategic planning, and resource allocation
• Strong knowledge of cGMP requirements, quality systems, CQV practices, automation and computerised systems, data integrity, and regulatory expectations
• Excellent written and verbal communication skills, with the ability to influence others as a team player
• Ability to handle multiple priorities simultaneously, with solid analytical skills

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.