Director of Engineering – Pharma Aseptic Filling

Director Of Equipment Engineering

Our client – a global and growing Bio Pharma CDMO company needs a Director of Equipment Engineering at their expanding plant in WA state. Excellent total comp up to $300K+ Full Benefits + Relocation Bonus.

Job Title:

Director of Engineering – Pharma Aseptic Filling

Location:

Spokane, WA

Overnight Travel: 10%

Relocation:
The client offers a generous Package for relocation assistance.

Compensation:
Salary range up to $250K base + Annual Bonus (20%)

Full Benefits:
Medical, Vision, Dental, 15 days ' vacation/Sick time, 10 - Holidays, 401k (match up to 4%)

Company Info:
Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries including around 1,300 people at this site in Spokane, WA.

This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.

Group Info:
Lead the Engineering group supporting the existing and expansion site in Spokane, WA. The group will have around 22 engineers reporting to this role including Manufacturing Engineering, Automation, Project Engineers/Managers, Reliability.

These 3 groups are separate and will not report to this role – Validation, Maintenance, Facilities

Note1:
The company recently completed their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are expanding again with a 4th line at this site.

Note 2:
This person will report to the Sr. Director of Engineering & Maintenance

Summary:

• The Director, Equipment Engineering delivers strategic and technical leadership for all equipment supporting aseptic GMP manufacturing and secondary packaging and inspection, including sterile liquid filling, lyophilization, and supporting utilities and space. This role ensures equipment is designed, qualified, maintained, and operated to meet the highest standards of sterility assurance, regulatory compliance, and supply reliability.
• The position is accountable for equipment lifecycle performance, enabling robust commercial supply, successful regulatory inspections, and seamless new product introduction (NPI) in a highly controlled aseptic environment.
• This role owns the full equipment lifecycle—from conceptual design and technical specification through installation, startup, commissioning (Cx), and validation support—ensuring systems are compliant, reliable, and fit for purpose.
• The role serves as the primary engineering subject matter expert during regulatory inspections and audits, representing equipment design, commissioning, and validation practices.

Job Description:

Engineering & Equipment Operations:

• Oversee day-to-day engineering and equipment activities for aseptic filling, isolators, and lyophilization equipment
• Ensure equipment reliability, preventive maintenance effectiveness, and reduced downtime
• Own lifecycle performance of equipment post-startup, ensuring sustained reliability, maintainability, and compliance

Project Execution:

• Lead and oversee engineering projects including design, specification, installation, startup, and commissioning (Cx) of equipment systems
• Ensure robust project execution through defined turnover processes, including FAT/SAT, commissioning plans, and performance verification
• Accountable for project timelines, budgets, and resource planning in alignment with site priorities

Design & Technical Oversight:

• Provide technical leadership in equipment design, selection, and specifications, ensuring alignment with process, operational, and regulatory requirements
• Ensure systems are designed for cleanability, maintainability, and compliance (cGMP)
• Oversee installation and construction activities, ensuring adherence to design intent and quality standards

Compliance & Quality:

• Serve as the primary engineering representative during regulatory inspections and client audits, providing subject matter expertise on equipment design, commissioning, and validation
• Ensure inspection readiness of all engineering documentation (e.g., URS, FS/DS, FAT/SAT, commissioning and validation records)
• Owns the basis of engineering technical expertise…