Director of Engineering, Validation & Maintenance

About the Role

The Director, 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 ongoing and future facility, utility, manufacturing, and laboratory systems throughout the life cycle of an asset.

The Director of EVM directly manages and is responsible for all staff involved in facilities, maintenance, project engineering, project validation, and calibration activities for the site. Responsibilities include:

• Engineering: project scope, cost estimates, schedules, design, procurement, and installation/construction.
• Validation: factory acceptance tests, commissioning, installation qualification, operational qualification, performance qualification, and re-qualification programs.
• Maintenance: preventative maintenance, work order repairs, metrology, and facilities programs including security, housekeeping, landscaping, and pest control.

The role supports the strategic development of the department’s organizational capabilities and 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.

Responsibilities

• Develops, implements, and maintains robust engineering, validation, and maintenance standards.
• Manages internal engineering, validation, and maintenance teams and processes while supporting other groups, including manufacturing and lab operations.
• Oversees the equipment, facilities, and utilities qualification program and drives innovation to remain current.
• Leads the design, implementation, monitoring, 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.
• Owns the integration of capital projects and asset strategies into the broader site master plan and infrastructure roadmap.
• Leads and actively participates in client interface regarding equipment, facility, and utility lifecycle.
• Oversees and develops the facility’s annual and long-term capital investment plan and departmental operating budget.
• Cultivates an efficient, professional, and safe working atmosphere while ensuring timely results.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Leads 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.
• Builds and develops a high-performing team through effective hiring, coaching, performance management, succession planning, and employee development.
• Sets priorities, allocates resources, and ensures timely execution of departmental objectives in support of site operations and business goals.
• Fosters a culture of safety, accountability, collaboration, and continuous improvement across the organization.
• Ensures compliance with cGMP, safety, and company training requirements, maintaining organizational readiness and capability.
• Partners cross-functionally with Operations, Quality, Technical, and Site Leadership to align Engineering, Validation, and Maintenance strategies with current and future site needs.

Requirements

• Bachelor’s degree in Engineering, Chemical, Mechanical, Biochemical, or equivalent required.
• 5-8 years of related experience required; 12+ years preferred.
• Expert knowledge in cGMP, engineering standards, methodologies, 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.
• Experience with customer interface and cross-functional/international business experience preferred.
• Proficient in Microsoft Office applications.
• Up to 5% travel required.

Skills

• Strategic leadership and team development.
• Cross-functional collaboration and stakeholder management.
• Budgeting and capital investment planning.
• Project management and execution.
• Compliance with cGMP, safety, and regulatory standards.

Other Details

• This position is eligible for a flexible schedule.
• This position is not eligible for remote/hybrid work.

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 and 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.
• The noise level is moderate to noisy. Occasionally, the employee may be exposed to airborne particles, fumes, chemicals, moving mechanical parts, and vibration.
• Must have the ability to wear PPE as required.

About the Company

Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast-growing, dynamic business with facilities in the UK and the US, employing more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and way of working set us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.