Director of Engineering & Maintenance

About the role

The Director of Engineering and Maintenance 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 of Engineering & Maintenance directly manages and is responsible for all staff involved in facilities, maintenance, project engineering, project validation, and calibration activities for the site.

Responsibilities

• Develops, implements, and maintains robust engineering, validation and maintenance standards.
• Manages internal engineering, validation and maintenance teams and processes as well as provides support to other groups including manufacturing and lab operations.
• Oversees the equipment, facilities and utilities qualification program and drives innovation to remain current.
• Led the design, implementation, monitoring and control and closure stages of major department and capital projects for the facility.
• Develops, governs, and continuously updates the site engineering master plan, aligning infrastructure, capacity, and utilities with long-term business and operational strategy.
• Leads cross-functional collaboration with operations, quality, and technical teams to translate User Requirement Specifications (URS) into robust, compliant, and cost-effective engineering designs and solutions.
• Owes the integration of capital projects and asset strategies into the broader site master plan and infrastructure roadmap.
• Leads and actively participates in client interface in regards to equipment, facility and utility lifecycle.
• Oversees and develops the facility annual and long-term capital investment plan and departmental operating budget.
• Cultivates an efficient, professional and safe working atmosphere and ensures timely results are achieved.
• Ensures 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 5 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.
• Ensure compliance with cGMP, safety, and company training requirements, maintaining organizational readiness and capability.
• Partner cross-functionally with Operations, Quality, Technical, and Site Leadership to align Engineering, Validation, and Maintenance strategies with current and future site needs.

Requirements

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications

• Expert knowledge in cGMP, engineering standards, methodologies and maintenance, project engineering, and validation lifecycle required.
• Knowledge of quality systems preferred.
• Excellent verbal and written communication, presentation skills, project management, organizational skills, detail orientation and business acumen required.
• Excellent experience with customer interface and preferred cross-functional and international business experience preferred.
• Proficient in Microsoft Office applications.

Skills

Duties, responsibilities, and activities may change at any time with or without notice.

Education and Experience

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

Other Qualifications, Skills and Abilities

• This position is eligible for a flexible schedule.
• This position is 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 of this Job, 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 and 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 by this job 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. Occasionally, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must have the ability to wear PPE as required. Employee occasionally may be exposed to moving mechanical parts and vibration.

Diversity and Inclusion

Sterling values diversity and we are 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.