Associate Director, Aseptic Filling Engineering

Jubilant Pharma, LLC; Spokane, Northern (WA, KY); Hybrid; USD 142,000 - 227,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

FSA/HSA

Life Insurance

AD&D

Disability Insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier in Spokane, WA, seeks an Associate Director Engineering to lead a team of engineers responsible for aseptic filling equipment design, installation, and qualification, ensuring cGMP compliance.

You will manage end-to-end projects, define technical requirements, collaborate with Manufacturing, Quality, and Validation, oversee IQ/OQ/PQ, and mentor 10-15 engineers while ensuring safety, quality, and continuous improvement.

Qualifications

• BS in Mechanical Engineering, Pharmaceutical, Manufacturing, or Industrial Engineering.
• 12+ years in pharmaceutical engineering, with at least 3 years in aseptic filling equipment projects.
• 5 years management of technical personnel.
• Proven track record of on time equipment design, installation, and qualification under cGMP.
• Strong knowledge of aseptic processing, isolator technology, and lyophilization.
• Excellent project management, leadership, and communication skills.
• Deep knowledge of regulatory guidelines (FDA, EMA, ICH) and ISPE.
• Ability to read CAD drawings, P&IDs, I&C documents, controls logic and hardware architecture.
• Strong mentoring skills.
• Office (Word, PowerPoint, Excel & SAP)

Responsibilities

• Manage end-to-end engineering projects for aseptic filling systems, isolators, lyophilizers, and component preparation equipment including concept design, procurement, installation, commissioning, and qualification.
• Develop and maintain project timelines, budgets, and resource plans.
• Define technical requirements for filling lines, filling assemblies, isolators, lyophilizers, component preparation 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.
• Prepare and review URS, FAT/SAT reports, and qualification protocols.
• Own equipment related deviation and CAPA investigation and remediation.
• Supervise and mentor a team of 10-15 technical engineers.
• Quality, select and manage equipment suppliers and contractors.

Skills

Project management

Leadership

Mentoring

Communication

Technical documentation

Education

BS in Mechanical Engineering

Tools

SAP

MS Office

Job description

Jubilant HollisterStier in Spokane, WA, seeks an Associate Director Engineering to lead a team of engineers responsible for aseptic filling equipment design, installation, and qualification, ensuring cGMP compliance.

You will manage end-to-end projects, define technical requirements, collaborate with Manufacturing, Quality, and Validation, oversee IQ/OQ/PQ, and mentor 10-15 engineers while ensuring safety, quality, and continuous improvement.