Engineering Sr. Manager/Engineering Associate Director
Listed on 2025-12-30
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Engineering
Validation Engineer, Quality Engineering
Sr. Engineering Manager
Jubilant Hollister Stier CMO—Spokane, WA. On-site, full‑time position.
Job OverviewThe Engineering Sr. 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.
Responsibilities- 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.
- 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, and 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.
- 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.
- Supervise and mentor a team of 10–15 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.
- BS in Mechanical Engineering, Pharmaceutical, Manufacturing, or Industrial Engineering.
- 8+ years in pharmaceutical engineering, with at least 3 years in aseptic filling equipment projects.
- 3 years of management experience with technical personnel.
- Proven track record of on‑time equipment design, installation, and qualification under cGMP guidelines.
- Experience with automated filling lines and robotics.
- Knowledge of cleanroom design and environmental monitoring systems.
- Ability to manage multiple projects in a fast‑paced environment.
- Strong knowledge of aseptic processing, isolator technology, and Lyophilization.
- Excellent project management, leadership and communication skills.
- Deep knowledge of regulatory guidelines (FDA, EMA, ICH) and related industry guidelines such as ISPE.
- Ability to read and understand technical documents such as CAD drawings, P&IDs, I&C documents, controls logic and hardware architecture.
- Working knowledge in Word, PowerPoint, Excel and SAP.
- Exposure to Allergens and working in an aseptic area.
- Parenteral Drug Association certification managing your isolate for aseptic processing (desired).
Weekday days, Monday‑Friday. This is an on‑site, full‑time position located in Spokane, WA.
Compensation & Benefits- Hiring Wage: $114,500 – $183,200 annually (depending on experience).
- Medical, Dental, Vision, Flexible Spending and Health Savings Accounts.
- Life, AD&D, Short and Long Term Disability.
- 401(k) with company match.
- Generous paid time off plan.
- Employee Assistance Program.
Pursue a career with Jubilant Hollister Stier. We are an EEO/AA employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If you require assistance applying for a position, please contact our HR Department at: JHS‑
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