Associate Director, Maintenance

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Oversee maintenance and reliability readiness initiatives for a growth investment project in the U.S.

• Ensure that the facility, equipment, utilities, process equipment, and maintenance systems are designed and implemented with a focus on long-term reliability, maintainability, mechanical integrity, and compliance with GMP standards.

• Collaborate closely with Engineering, Operations, Automation, MSAT, and Quality teams to establish the maintenance organization, systems, and processes necessary for a successful site start-up and ongoing operations.

• Provide leadership in maintenance and reliability throughout the phases of facility design, construction, commissioning, qualification, and start-up activities.

• Formulate maintenance strategies, including preventive, predictive, and reliability-centered maintenance programs to enhance long-term asset performance.

• Work with Engineering and project teams to ensure that maintainability, serviceability, accessibility, and lifecycle considerations are integrated into the design of facilities and equipment.

• Develop asset lifecycle management strategies, which include spare parts planning, calibration programs, and equipment reliability initiatives.

• Assist in the selection, implementation, and optimization of CMMS and other maintenance technologies to facilitate effective planning and execution.

• Engage in commissioning, qualification, FAT/SAT, and operational readiness activities to ensure that maintenance requirements are incorporated and validated.

• Define the future maintenance organization, outlining staffing plans, training requirements, operating procedures, and site support models.

• Identify and address risks related to equipment reliability, maintenance, and operational readiness, providing regular updates and recommendations to project leadership.

⛳️ Requirements

• Bachelor's degree in engineering, Facilities Management, Reliability Engineering, or a related technical field; advanced degree is preferred.

• Over 10 years of experience in maintenance, reliability, engineering, or technical operations within pharmaceutical or API manufacturing settings.

• Preferred experience with HPAPI, complex chemical synthesis, or chemical process manufacturing.

• Proven track record supporting major capital projects, facility start-ups, manufacturing expansions, greenfield or brownfield investments, or large-scale operational readiness initiatives.

• Strong understanding of maintenance best practices, reliability engineering, asset lifecycle management, and enhancing equipment performance.

• Familiarity with CMMS platforms, predictive maintenance technologies, reliability-centered maintenance (RCM), and maintenance planning systems.

• Knowledge of GMP requirements concerning equipment maintenance, calibration, qualification, documentation, inspection readiness, and mechanical integrity principles.

• Demonstrated experience in supporting small molecule drug substance, API, or HPAPI manufacturing operations is preferred.

• Experience in containment-intensive manufacturing environments (e.g., HPAPI containment, isolators, contained material handling) is preferred.

• Preferred experience in a multi-product API manufacturing or CDMO environment.

• Excellent leadership, communication, collaboration, and problem-solving skills, with the ability to influence cross-functional teams and stakeholders.

• Willingness to relocate to an East Coast or Midwest U.S. site as project demands change.

• Openness to travel to EMEA and NA approximately 25-30% of the time to achieve business objectives.

🏝️ Benefits

• Performance-related bonus.

• Medical, dental, and vision insurance.

• 401(k) matching plan.

• Life insurance, along with short-term and long-term disability insurance.

• Employee assistance programs.

• Paid time off (PTO).