Jubilant HollisterStier CMO · 1 month ago
Engineering Sr. Manager/Engineering Associate Director
Spokane, WA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$114K/yr - $183K/yr
8+ years expJubilant HollisterStier LLC is Spokane’s Largest Manufacturing Company, providing a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Engineering Sr. Manager/Engineering Associate Director will lead a team of technical professionals in the design, installation, qualification, and ongoing operational improvement of aseptic filling equipment for pharmaceutical products, ensuring compliance with regulatory requirements and industry best practices.
Travel
Hiring Manager
Paige Ford
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
Qualification
Required
BS in: Mechanical Engineering, Pharmaceutical, Manufacturing, or Industrial Engineering required
8+ years in pharmaceutical engineering, with at least 3 years in aseptic filling equipment projects required
3 years management technical personnel required
Proven track record of on time equipment design, installation, and qualification under cGMP guidelines required
Strong knowledge of aseptic processing, isolator technology, and Lyophilization required
Excellent project management, leadership, and communication skills required
Deep knowledge of regulatory guidelines (FDA, EMA, ICH) and related industry guidelines such as ISPE required
Ability to read and understand technical documents of all types such as CAD drawings, P&IDs, I&C documents, controls logic and hardware architecture required
Strong mentoring skills required
Working knowledge in Word, PowerPoint, Excel and SAP required
Exposure to Allergens and working in Aseptic Area required
Preferred
ISPE GAMP Essentials desired
ISPE Good Engineering Practices desired
ISPE Biopharmaceutical Essentials desired
Parenteral Drug Association Aseptic Processing desired
Parenteral Drug Association Annex 1 desired
Parenteral Drug Association Manage your Isolator for Aseptic Processing desired
PMI Project Management Professional desired
ISA CAP desired
Experience with automated filling lines and robotics desired
Knowledge of cleanroom design and environmental monitoring systems desired
Ability to manage multiple projects in a fast-paced environment desired
Benefits
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
Company
Jubilant HollisterStier CMO
Jubilant HollisterStier (JHS) CMO provides comprehensive sterile fill-finish and lyophilization services, ensuring the consistent delivery of high-quality products that meet the needs of global healthcare markets and patients worldwide.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Chris Preti
Chief Executive Officer
Ian Fuller
Vice President Operations - CMO
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