Director of Engineering - Pharma Aseptic Filling

Our client – a global and growing  BioPharma 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 Posting # 2720R

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 that drives policies and procedures to achieve regulatory compliance, industry standards and best practices for producing safe, compliance and effective pharmaceutical products.
• Drive timely and technically sound support for deviations, investigations, and CAPAs related to equipment and systems.
• Ensure all equipment supports aseptic process control strategy, including:
• Contamination control (CCS alignment)
• Annex 1 (EU GMP) compliance
• FDA aseptic processing expectations
• Partner with Quality to maintain inspection readiness (FDA, EMA, MHRA)
• Own engineering aspects of:
• Deviations / investigations
• Change control
• Media fill readiness support
• Ensure systems align with validated environmental and process controls

Team Leadership:

• Drive a culture of ownership, safety, accountability, and continuous improvement.

Vendor & Contractor Management:

• Support vendor selection, coordination, and performance management
• Ensure timely delivery of services and adherence to quality standards
• Oversee vendor execution during design, installation, and commissioning phases to ensure compliance with project and quality expectations

Commissioning, Startup & Validation

• Lead and oversee startup and commissioning (Cx) activities, ensuring systems are installed and operate as intended
• Ensure execution of structured commissioning processes, including functional testing and equipment readiness
• Provide engineering oversight and support for validation activities (IQ/OQ/PQ) in partnership with Validation and Quality
• Ensure all turnover and validation documentation is complete, accurate, and inspection-ready 

Candidate Must Have:  

• Bachelor's degree in a technical & related field.
• 12+ years in pharmaceutical engineering
• 3+ years in  pharmaceutica l  aseptic processing  and equipment lifecycle Mgmt.
• 5+ years of  Engineering   Department Management experience
• Ability to work in a fast-paced  Pharma contract Manufacturing organization (CDMO)
• Strong expertise commissioning (Cx), and validation practices (IQ/OQ/PQ)
• Proven ability to support regulatory inspections and compliance activities
• Project execution and capital project delivery
• Strong expertise in technical design, creative solutioning and troubleshooting skills 

Candidate Nice to Have:  

• Degree in Engineering - Mechanical, Manufacturing, Industrial, Pharmaceutical
• Advanced degree in  Engineering or  MBA
• PMI certification in Project Management Professional –  PMP
• Professional Engineer –  PE License
• Automation experience using  PLC/HMI/SCADA  systems
• Experience working in a fast-paced  Pharma Contract Manufacturing Organization (CDMO)
• Certifications in any of the following: 

• ISPE GAMP Essentials
• ISPE Good Engineering Practices
• ISPE Biopharmaceutical Essentials
• Parenteral Drug Association Aseptic Processing
• Parenteral Drug Association Annex 1
• Parenteral Drug Association Manage your Isolator for Aseptic Processing
• PMI Project Management Professional
• ISA CAP

  Keywords:  Projects, Director, engineering, Pharma, CDMO, manufacturing, plant, FDA, GMP, Sterile Aseptic liquid filling, Isolators, Clean rooms, Lyophilization, contract Manufacturing,  PE, PMP