US Director, Facilities and Engineering

AdvanCell Pty Ltd.; Andover (MN); On-site; USD 160,000 - 240,000; Full time

Job summary

AdvanCell Pty Ltd. is seeking a Director of Facilities & Engineering for its Andover site. You will lead facilities, utilities, and infrastructure to support GMP manufacturing, working through construction transition to commissioning and operational readiness.

You will collaborate with MSAT, Quality, HSE, Supply Chain, IT/OT, and R&D while shaping the operating model, standards, and team for scalable, compliant operations and future site expansion.

Qualifications

• Minimum 10 years of progressive facilities or site operations leadership in GMP environments.
• Strong knowledge of utilities, HVAC, cleanrooms, and facility infrastructure.
• Experience with capital projects, budget management, and contractor oversight.
• Proven ability to lead cross-functional teams and ensure compliance with GMP/EHS standards.
• Experience supporting CQV, validation, inspections, and regulatory commitments.

Responsibilities

• Lead Andover Facilities & Engineering to ensure safe, reliable, compliant operations.
• Oversee construction transition, commissioning, qualification, and readiness.
• Maintain GMP infrastructure, utilities, HVAC, cleanrooms, and critical systems.
• Establish preventive maintenance, reliability programs, and spare-parts strategies.
• Partner with CQV, Quality, and project teams to support validation and release.
• Manage radiopharmaceutical infrastructure, radiation safety, and regulatory alignment.
• Lead capital projects from scope to handover and plan future expansions.
• Set engineering standards, docs, asset management, and process controls.
• Develop contingency plans, emergency response, and business continuity.

Skills

Facilities leadership

GMP compliance

HVAC & cleanrooms

Capital projects

Vendor management

Regulatory readiness

Project management

Risk & reliability

Team leadership

Education

Bachelor’s degree in Engineering

Facilities management certification

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.