Sr. Manager Engineering - Pharmaceutical Aseptic Filling

Our client - a global and growing BioPharma CDMO company needs a Sr. Manager of Engineering at their expanding plant in WA state . Excellent total compensation up to $250K+ with good benefits and relocation bonus. Job Posting # 2697 Job Title: Sr. Manager Engineering - Pharma Aseptic Filling Location: Spokane, WA Overnight Travel: 10% Relocation: The client offers a lumpsum bonus for relocation assistance. Compensation: Salary range $160K - $215K + Annual Bonus (15%) Full Benefits: Medical, Vision, Dental, 15 days vacation/sick time, Holidays, 401k (match up to 5%). Company Info: Our client is a growing CDMO company in the Pharmaceutical Industry, part of a global parent company with sites in many countries and about 1,300 people at this site in Spokane, WA. This is an integrated contract development and manufacturing organization 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 10 engineers reporting to this role, including Manufacturing Engineering, Automation, Project Engineers/Managers. Key Highlights Completed 3rd state‑of‑the‑art sterile liquid compounding & vial filling line, currently expanding with a 4th line at this site. Hands‑on role leading the team by example and performing strategic engineering work. Can be top graded to an Associate Director for the right level of experience. Summary The Sr. Engineering Manager 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. Job Description Project Leadership 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. Design & Specifications 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. Installation & Qualification Oversee equipment installation and integration into existing facilities. Lead IQ/OQ/PQ activities in alignment with validation protocols and regulatory standards. Compliance & 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 technical engineers. Foster a culture of safety, quality, and continuous improvement. Vendor Management Identify, select, and manage equipment suppliers and contractors. Negotiate contracts and ensure timely delivery of equipment and services. 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: 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, Assoc Director, engineering, Pharma, CDMO, manufacturing, plant, FDA, GMP, Sterile Aseptic liquid filling, Isolators, Clean rooms, Lyophilization, contract Manufacturing, Manager, PE, PMP. #J-18808-Ljbffr