Associate Director, Engineering

Job Description

The Associate Director of Engineering and Maintenance serves as the site engineering lead for the startup of a pharmaceutical filling and lyophilization facility. This position has a broad range of responsibilities with opportunities to grow and develop to higher levels of management within our company's Animal Health organization.

 Specifically, the Associate Director will partner with our Global Engineering team to build and lead the commissioning, qualification, and validation of a new pharmaceutical filling and lyophilization facility. This role will ensure compliance with USDA, and industry regulations while overseeing the successful startup of aseptic manufacturing operations, including vial filling and freeze-drying processes. Significantly, this individual will build and manage an engineering team capable of supporting long-term operations.

Responsibilities:

• Serve as site engineering lead within a start up filling and lyophilization facility.

• Provide leadership and vision for the startup site Engineering and Maintenance teams during construction, commissioning and qualification of the facility.

• Lead the commissioning and qualification of pharmaceutical filling and lyophilization equipment, clean utilities, and facility systems.

• Manage Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for critical equipment.

• Troubleshoot and optimize equipment performance during startup.

• Work closely with internal stakeholders, equipment vendors, and contractors to ensure timely and compliant startup.

• Recruit, hire, and train a high-performing engineering team to support facility startup and ongoing operations.

• Define roles and responsibilities for key engineering functions, including maintenance, , utilities, and process engineering.

• Provide leadership, mentorship, and professional development for engineering staff.

• Develop a robust preventive maintenance and reliability engineering program to ensure long-term facility performance.

• Collaborate with manufacturing, quality, and regulatory teams to align validation strategies with business goals.

• Develop and maintain project timelines, ensuring key milestones are met.

• Ensure compliance with data integrity and automation best practices.

• Support regulatory audits and inspections, addressing CQV and engineering-related queries.

• Additional duties as assigned

Minimum education required:

• Bachelor’s degree in engineering

• MBA or master’s degree in Engineering preferred.

Required Experience and Skills:

• 8-10 years of relevant  experience with Construction, Plant engineering and/or Manufacturing environments.

• Possess flexible leadership skills with an ability to staff and lead Engineering Teams.

• Must have experience with Capital Construction projects and People Management experience

• Prior experience with Project Management and Financial execution

• Experience in a USDA or FDA manufacturing environment

• Ability to communicate effectively with all levels of the organization on site and above site management.

• Proven project and construction management capabilities

• Good equipment / process trouble shooting skills.

Preferred Experience and Skills:

• Biotechnology manufacturing / sterile processing and lyophilisation experience

• Knowledge / experience with process validation (URS, FRS, IOQ, PQ)

• Knowledge of automation (SCADA, BMS, PLCs, DCS)

• Good understanding of mechanical, electrical, and plumbing (MEP) system design

• Proficient in using PC applications, including Microsoft Office Suite (Outlook, Excel, Word, Project) and Adobe.

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