Director of Engineering, Validation and Maintenance (EVM)

Summary of Role

Director of Engineering, Validation and Maintenance (EVM) is accountable for driving results in a fast‑paced environment by developing and executing engineering, validation, and maintenance strategies supporting on‑going and future facility, utility, manufacturing and laboratory systems throughout the life cycle of an asset. The Director directly manages and is responsible for all staff involved in facilities, maintenance, project engineering, validation, and calibration activities for the site. Engineering includes project scope, cost estimates, schedules, design, procurement, and installation/construction. Validation includes factory acceptance tests, commissioning, installation qualification, operational qualification, performance qualification, and re‑qualification program. Maintenance includes preventative maintenance, work order repairs, metrology, and facilities programs including security, housekeeping, landscaping and pest control. The Director also supports the strategic development of the department’s organizational capabilities. This role provides strategic leadership for the site master plan, ensuring alignment with business growth, operational requirements, and long‑term infrastructure needs. The Director translates User Requirement Specifications (URS) from operations into scalable, compliant, and efficient engineering solutions. The position requires execution of Sterling Values and non‑negotiables and expertise in functional competencies included in this position profile.

Essential Functions

• Develop, implement, and maintain robust engineering, validation and maintenance standards.
• Manage internal engineering, validation, and maintenance teams and processes; provide support to other groups including manufacturing and laboratory operations.
• Oversee the equipment, facilities and utilities qualification program and drive innovation to remain current.
• Lead the design, implementation, monitoring, control and closure stages of major department and capital projects for the facility.
• Develop, govern, and continuously update the site engineering master plan, aligning infrastructure, capacity and utilities with long‑term business and operational strategy.
• Lead cross‑functional collaboration with operations, quality, and technical teams to translate URS into robust, compliant, and cost‑effective engineering designs and solutions.
• Own the integration of capital projects and asset strategies into the broader site master plan and infrastructure roadmap.
• Lead and actively participate in client interfaces regarding equipment, facility and utility lifecycle.
• Oversee and develop the facility annual and long‑term capital investment plan and departmental operating budget.
• Cultivate an efficient, professional and safe working atmosphere and ensure timely results.
• Ensure timely completion and compliance with cGMP and all other relevant company training requirements.
• Lead the Germantown Engineering, Validation and Maintenance organization, providing strategic direction and day‑to‑day leadership for managers and site teams, including five direct and 15+ indirect reports.
• Build and develop a high‑performing team through effective hiring, coaching, performance management, succession planning, and employee development.
• Set priorities, allocate resources, and ensure timely execution of departmental objectives in support of site operations and business goals.
• Foster a culture of safety, accountability, collaboration, and continuous improvement across the organization.
• Partner cross‑functionally with Operations, Quality, Technical, and Site Leadership to align Engineering, Validation, and Maintenance strategies with current and future site needs.

Key Competencies

• Expert knowledge in cGMP, engineering standards, methodologies and maintenance, project engineering, and validation lifecycle.
• Knowledge of quality systems preferred.
• Excellent verbal and written communication, presentation skills, project management, organizational skills, detail orientation and business acumen.
• Experience with customer interface and cross‑functional and international business experience preferred.
• Proficiency in Microsoft Office applications.
• Activities may change at any time with or without notice.

Education and Experience

• Bachelor’s degree in Engineering, Chemical, Mechanical, Biochemical or equivalent.
• 5–8 years of related experience required; 12+ years preferred.

Certifications, Business Licenses, Registrations

• None.

Travel Requirement

• Up to 5% travel required.

Other Qualifications, Skills and Abilities

• Position eligible for a flexible schedule.
• Position not eligible for remote/hybrid work location.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties, the employee is regularly required to use hands to finger, handle or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand, walk, stoop, kneel, crouch or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level is moderate to noisy. The employee may be exposed to airborne particles and fumes, chemicals, moving mechanical parts and vibration. Employee must wear PPE as required.

Diversity and Inclusion

Sterling values diversity and is committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identity or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.