Associate Director of Engineering

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

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.

Project:

• 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.

Required Skills:

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