US Director, Facilities and Engineering

AdvanCell

Andover (MA)

On-site

USD 160,000 - 240,000

Full time

7 days ago
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Job summary

AdvanCell seeks a Director of Facilities & Engineering to lead the Andover manufacturing site, overseeing facilities, utilities, equipment, and infrastructure to support GMP manufacturing. The role guides construction transition, qualification, and readiness for commercial operations, ensuring safe, compliant, and scalable operations.

The candidate will manage critical utilities, capital projects, and cross-functional partnerships with MSAT, Quality, HSE, and R&D to enable ongoing site expansion

Qualifications

  • Minimum 10 years of progressive facilities/engineering leadership experience within GMP manufacturing.
  • Strong project, financial, and vendor-management capabilities.
  • Experience with GMP, validation/CQV, EHS, radiation safety, regulatory inspections, and change control.
  • Ability to build organizational capability, establish operating systems and standards, and develop talent.
  • Demonstrated risk-management, decision-making, and balance of reliability, cost, and scalability.

Responsibilities

  • Lead facilities & engineering for GMP manufacturing site in Andover.
  • Oversee construction transition to commissioning and routine operations.
  • Ensure facilities infrastructure, utilities, HVAC, cleanrooms, and systems are reliable.
  • Develop and manage capital budgets and project portfolios; manage contractors and vendors.
  • Ensure regulatory compliance, inspections readiness, and safety programs.
  • Collaborate with cross-functional teams to translate requirements into scalable solutions.

Skills

Facilities leadership
GMP manufacturing
Capital project delivery
Vendor management
Regulatory compliance
Budget management
Cross-functional collaboration

Education

Bachelor's degree in Engineering
Facilities management certifications

Job description

The Director of Facilities & Engineering is responsible for the technical and operational leadership of AdvanCell’s Andover manufacturing site, ensuring the facility, utilities, equipment, and infrastructure are safe, reliable, compliant, and capable of supporting commercial operations.

As the Andover site is currently under construction, this role will be critical to the successful transition from construction through commissioning, qualification, operational readiness, clinical manufacturing, and commercial scale-up.

The role oversees facilities management, engineering, maintenance, critical utilities, site infrastructure, contractor management, reliability, capital planning, and facilities-related systems. The Director will establish the operating model, standards, processes, and team required to transition the site from project delivery into a high-performing GMP manufacturing operation.

The role will work closely with Manufacturing, MSAT, Quality, HSE, Supply Chain, IT/OT, CMC, R&D, and external engineering and service providers to ensure the site is operationally ready, compliant, reliable, and scalable. The Director will also serve as a key technical leader in planning and executing future site expansion and infrastructure investments.

Key Responsibilities & Duties
  • Site Facilities & Engineering Leadership. Establish and lead the Andover Facilities & Engineering function, ensuring safe, reliable, compliant, and efficient operation of all site facilities, utilities, infrastructure, and engineering systems supporting GMP manufacturing and site operations.
  • Construction Transition & Operational Readiness. Lead the transition from construction into commissioning, qualification, and routine operations. Ensure clear ownership, documentation, training, maintenance strategies, spare parts, procedures, and operational readiness are established prior to handover.
  • GMP Manufacturing Infrastructure. Ensure facilities, utilities, HVAC, environmental controls, cleanrooms, critical systems, and manufacturing infrastructure reliably support GMP operations and applicable regulatory requirements.
  • Critical Utilities & Reliability. Establish preventive maintenance, reliability, calibration, monitoring, and lifecycle-management programs for critical utilities and site infrastructure. Develop appropriate redundancy, contingency, and spare-parts strategies for systems critical to manufacturing continuity.
  • CQV & Validation Partnership. Partner with CQV, Quality, Engineering, and project teams to support commissioning, qualification, validation, deviation resolution, and successful release of facilities, utilities, and equipment for GMP use.
  • Radiopharmaceutical Infrastructure. Ensure facilities and infrastructure support the safe handling, production, storage, and movement of radioactive materials and radiopharmaceutical products in accordance with applicable radiation safety, GMP, EHS, and regulatory requirements. Partner closely with Radiation Safety and EHS leadership.
  • Capital Projects & Site Expansion. Lead facilities and engineering projects from scope development and design through construction, commissioning, qualification, and operational handover. Develop business cases and capital plans to support future capacity expansion and commercial readiness.
  • Engineering Systems & Technical Standards. Establish engineering standards, maintenance strategies, documentation, asset-management practices, and technical procedures that support a consistent and scalable site operating model.
  • Business Continuity & Emergency Preparedness. Establish infrastructure contingency plans, emergency response capabilities, utility redundancy, disaster recovery measures, and business continuity strategies for critical site operations.
  • Vendor & Contractor Management. Select and manage engineering firms, maintenance providers, contractors, equipment suppliers, and other service providers. Establish clear performance expectations, service levels, safety requirements, and accountability.
  • Budget & Resource Management. Develop and manage Facilities & Engineering operating and capital budgets, forecast future infrastructure requirements, and optimize resources and expenditures while maintaining appropriate reliability and compliance.
  • Regulatory & GMP Compliance. Ensure facilities and engineering systems remain compliant with GMP, EHS, radiation safety, building and environmental requirements, and applicable regulatory expectations. Support inspections, audits, investigations, and regulatory commitments as required.
  • Cross-Functional Partnership. Partner closely with Manufacturing, MSAT, Quality, EHS/Radiation Safety, Supply Chain, IT/OT, CMC, R&D, and other functions to translate operational requirements into reliable and scalable facility and infrastructure solutions.
  • Team Leadership. Build and develop a high-performing Facilities & Engineering organization, establishing clear roles, responsibilities, operating rhythms, performance expectations, and development opportunities as the Andover site scales.
Essential Skills, Qualifications, Industry and Educational Requirements
  • Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial, or Facilities Engineering), Facilities Management, or a related technical discipline.
  • Relevant certifications in facilities, maintenance, reliability, or project management.
  • Minimum 10 years of progressive facilities, engineering, or site operations leadership experience within a GMP-regulated pharmaceutical, biotechnology, or related manufacturing environment.
  • Strong technical expertise in critical utilities, HVAC, cleanrooms, facility infrastructure, maintenance and reliability, engineering systems, and capital project delivery.
  • Experience working within highly regulated environments, including GMP, validation/CQV, EHS, radiation safety, regulatory inspections, and change control.
  • Strong project, financial, and vendor-management capabilities, including experience managing capital projects, operating budgets, contractors, engineering firms, and strategic service providers.
  • Strong problem-solving, risk-management, and decision-making skills, with the ability to balance operational urgency, compliance, reliability, cost, and long-term scalability.
  • Demonstrated ability to build organizational capability, establish operating systems and standards, develop talent, and create a culture of accountability, safety, reliability, and continuous improvement.

$160,000 - $240,000 a year

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

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