Candidate Must Have:
Bachelor's degree in a technical & related field.
8+ years in pharmaceutical engineering
3+ years in pharmaceutical aseptic filling
3+ years of Engineering Department Management experience
Ability to work in a fast-paced Pharma contract Manufacturing organization (CDMO)
Candidate Nice to Have:
Bachelor’s 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 Rockwell PLC/HMI/SCADA systems
Experience working in a fast-paced Pharma Contract Manufacturing Organization (CDMO)
Certifications in any of the following:
o ISPE GAMP Essentials
o ISPE Good Engineering Practices
o ISPE Biopharmaceutical Essentials
o Parenteral Drug Association Aseptic Processing
o Parenteral Drug Association Annex 1
o Parenteral Drug Association Manage your Isolator for Aseptic Processing
o PMI Project Management Professional
o ISA CAP
Job Description:
1. Project Leadership:
a. Manage end-to-end engineering projects for aseptic filling systems, isolators, lyophilizers, and component preparation equipment including concept design, procurement, installation, commissioning, and qualification.
b. Develop and maintain project timelines, budgets, and resource plans.
2. Design & Specifications:
a. Define technical requirements for filling lines, filling assemblies, isolators, lyophilizers, component preparation equipment, product and diluent vessels and associated SCADA components.
b. Collaborate with cross-functional teams (Manufacturing, Quality, Validation) to ensure equipment meets process and regulatory needs.
3. Installation & Qualification:
a. Oversee equipment installation and integration into existing facilities.
b. Lead IQ/OQ/PQ activities in alignment with validation protocols and regulatory standards.
4. Compliance and Documentation:
a. Ensure adherence to global regulatory requirements and guidelines for aseptic processing and regulatory standards.
b. Prepare and review engineering documentation, including URS, FAT/SAT reports, and qualification protocols.
c. Own equipment related deviation and CAPA investigation and remediation.
5. Team Management:
a. Supervise and mentor a team of 10 technical engineers.
b. Foster a culture of safety, quality, and continuous improvement.
6. Vendor Management:
a. Quality, select and manage equipment suppliers and contractors.
b. Negotiate contracts and ensure timely delivery of equipment and services.
Summary:
The 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.
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 is a hands-on role and the candidate is expected to lead the team by example and perform some strategic engineering work and also lead this group. He will report to the Sr. Director of Engineering.