Director of Engineering Facilities and Utilities

About the Company: American Injectables is a fast-growing Contract Development and Manufacturing Organization (CDMO) specializing in injectable pharmaceuticals. We are expanding our capabilities and investing in additional capabilities to enhance our turnkey solutions. As part of this expansion, we are seeking an experienced Director of Engineering for our manufacturing site with deep expertise in aseptic pharmaceutical manufacturing , process design, utilities, facilities, and packaging equipment.

About the Role: The Director will be responsible for a team of technicians working to maintain the facility equipment, plan for capacity and new equipment expansion, handle calibrations/metrology, and maintain the general working order of all GMP equipment in a compliant manner with US FDA and EU requirements.

Responsibilities:

• Consistently meet project and operational schedules with a high level of quality, professionalism, and compliance.
• Ensure all assigned areas operate in alignment with cGMP, Standard Operating Procedures (SOPs), and company policies—maintaining GMP spaces in a continuous state of control.
• Oversee the maintenance and performance of facilities, utilities, and equipment to fully support manufacturing and laboratory operations.
• Lead the planning, procurement, and installation of both minor and major equipment upgrades and expansions.
• Own the preparation, execution, and documentation of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for all relevant equipment, utilities, and facilities.
• Ensure all assets are properly maintained, serviced, and documented in accordance with regulatory and internal standards.
• Coordinate and oversee semi-annual shutdowns for preventative maintenance and calibration activities.
• Develop and manage capital expenditure (CapEx) plans and budgets, while maintaining responsibility for departmental budgeting.
• Create, review, and maintain SOPs related to engineering, facilities, and utilities operations.
• Recruit, develop, and lead a high-performing technical team to support a growing operation.
• Contribute to cross-functional initiatives and support special projects and ad hoc assignments as needed.

Qualifications:

• Bachelor’s degree in Engineering required; advanced degree preferred.
• Minimum of 3 years of hands-on experience in a pharmaceutical manufacturing environment.
• Strong foundation in process engineering and mechanical systems.
• Proven expertise in troubleshooting PLC-driven equipment and automated processes.
• Demonstrated success in leading complex capital projects with excellent project management skills and training.
• Proficiency in Microsoft Excel, Project, PowerPoint, and Word.
• Outstanding verbal and written communication abilities.
• Strong leadership and interpersonal skills with a track record of effectively managing technical teams, including engineers, technicians, and support staff in a dynamic, fast-growing environment.

Physical:

• Employees must be able to lift or handle objects not more than 50 pounds to perform certain duties essential to the job function.
• Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices.
• Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents (including potent compounds).
• Employees must be able to wear a respiratory protection (filtering facepiece, 1/2 face, full-face, or powered air purifying respirator, supplied air, or self contained breathing apparatus) for certain tasks essential to the job function.

Training: Must successfully complete all departmental training modules and meet the requirements as part of ongoing training.