Associate Director of Engineering

The Engineering Associate Director will lead a team of technical professionals responsible for the design, installation, qualification, and ongoing operational improvement of state-of-the-art aseptic filling equipment for liquid and lyophilized pharmaceutical products. This role ensures compliance with cGMP, regulatory requirements, and industry best practices while driving reliability, innovation and efficiency in sterile manufacturing operations.

• Manage end-to-end engineering projects for aseptic filling systems, isolators, lyophilizers, and component preperation equipment including concept design, procurement, installation, commissioning, and qualification.
• Develop and maintain project timelines, budgets, and resource plans.

Design & Specifications:

• Define technical requirements for filling lines, filling assemblies, isolators, lyophilizers, component preperation equipment, product and diluent vessels and associated SCADA components.
• Collaborate with cross-functional teams (Manufacturing, Quality, Validation) to ensure equipment meets process and regulatory needs.
• Oversee equipment installation and integration into existing facilities.
• Lead IQ/OQ/PQ activities in alignment with validation protocols and regulatory standards.

Compliance and Documentation:

• Ensure adherence to global regulatory requirements and guidelines for aseptic processing and regulatory standards.
• Prepare and review engineering documentation, including URS, FAT/SAT reports, and qualification protocols.
• Own equipment related deviation and CAPA investigation and remediation.

Team Management:

• Supervise and mentor a team of 10-15 technical engineers.
• Foster a culture of safety, quality, and continuous improvement.
• Quality, select and manage equipment suppliers and contractors.
• Negotiate contracts and ensure timely delivery of equipment and services.

• BS in:
  Mechanical Engineering, Pharmaceutical, Manufacturing, or Industrial Engineering
• 12+ years in pharmaceutical engineering, with at least 3 years in aseptic filling equipment projects.