Associate Director, Aseptic Engineering & Projects

ALKU; Spokane (WA); On-site; USD 140,000 - 190,000; Full time

Job summary

ALKU is seeking an Engineering Associate Director to lead a team of technical professionals responsible for aseptic filling equipment design, installation, qualification, and ongoing operational improvement. The role ensures cGMP compliance and regulatory adherence while driving reliability and efficiency in sterile manufacturing operations.

The successful candidate will manage end-to-end projects for isolators, lyophilizers, and related equipment, develop timelines and budgets, and mentor a

Qualifications

• 12+ years in pharmaceutical engineering, with at least 3 years in aseptic filling equipment projects.
• Experience leading a team of engineers and coordinating cross-functional activities to meet regulatory standards.

Responsibilities

• Design and manage end-to-end aseptic filling projects for liquids and lyophilized products.
• Lead IQ/OQ/PQ activities and validation protocols in alignment with cGMP requirements.
• Oversee installation and integration of equipment into existing facilities.
• Mentor and supervise 10–15 engineers, driving safety, quality, and continuous improvement.

Skills

Team leadership

Project management

Aseptic filling equipment

Regulatory compliance

IQ/OQ/PQ validation

Vendor management

Cross-functional collaboration

Education

BS in Mechanical Engineering / Pharmaceutical / Manufacturing / Industrial Engineering

Job description

ALKU is seeking an Engineering Associate Director to lead a team of technical professionals responsible for aseptic filling equipment design, installation, qualification, and ongoing operational improvement. The role ensures cGMP compliance and regulatory adherence while driving reliability and efficiency in sterile manufacturing operations.

The successful candidate will manage end-to-end projects for isolators, lyophilizers, and related equipment, develop timelines and budgets, and mentor a