Engineering Sr. Manager / Associate Director – Pharma Aseptic Filling
management recruiters of edisonSpokane (WA)
Engineering Sr. Manager / Associate Director – Pharma Aseptic Filling
Posted today
management recruiters of edisonSpokane (WA)
SENIORITY
Manager
About the role
Our client:
a global and growing BioPharma CDMO company needs a Sr. Manager of Engineering at their expanding plant in WA state, Excellent total comp. up to $250K+ with good Benefits + Relocation Bonus. Job Posting # 2699RJob Title Engineering Sr. Manager / Associate Director (See Note 3) – Pharma Aseptic Filling LocationSpokane, WA Overnight Travel: 10%Relocation The client offers a lumpsum bonus for relo assistance. Compensation Salary range up to $215K base + Annual Bonus (15%)Full Benefits Medical, Vision, Dental, 15 days' vacation/Sick time, 10 - Holidays, 401k (match up to 4%).Company InfoOur 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.Group InfoLead 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. Note1The company recently completed their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are currently expanding again with a 4th line at this site. Note 2This is a hands-on role and the manager 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. Note 3This role can be top graded to an Associate Director for the right person with this 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:
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.
- Oversee equipment installation and integration into existing facilities.
- Lead IQ/OQ/PQ activities in alignment with validation protocols and regulatory standards.
- Compliance and 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.
- Quality, select and manage equipment suppliers and contractors.
- Negotiate contracts and ensure timely delivery of equipment and services.
- Candidate Must HaveBachelor'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 HaveBachelor's degree in Engineering - Mechanical, Manufacturing, Industrial, Pharmaceutical
- Advanced degree in Engineering or MBAPMI certification in Project Management Professional – PMPProfessional 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 Biopharmaceutical Essentials
- Parenteral Drug Association Aseptic Processing
Parenteral Drug Association Annex 1Parenteral Drug Association Manage your Isolator for Aseptic ProcessingPMI Project Management ProfessionalISA CAPKeywordsProjects, Assoc Director, engineering, Pharma, CDMO, manufacturing, plant, FDA, GMP, Sterile Aseptic liquid filling, Isolators, Clean rooms, Lyophilization, contract Manufacturing, Manager, PE, PMP
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