Jubilant HollisterStier CMO · 5 hours ago
Principal / Senior Process Engineer
Jubilant HollisterStier LLC, Spokane’s largest manufacturing company, is rapidly expanding operations and is seeking multiple Principal/Senior Process Engineers to lead product ownership and process engineering for sterile injectable products. The role involves technical transfer, compliance leadership, and continuous improvement in a cGMP environment.
Travel
Responsibilities
Lead technical transfer and life cycle management of new products from internal and external clients
Serve as an authority on scientific principles, regulatory guidance, and technical aspects of site processes, providing leadership and direction to maintain compliance and optimize operations
Support regulatory audits and collaborate with cross-functional teams to address quality issues
Monitor process performance, troubleshoot deviations in real time (including occasional off-shift support), initiate and implement change controls, and drive effective CAPAs
Maintain deep knowledge of cGMP, USP, EU regulations, and clean-room science for media fills, sterilization, and microbiological control
Operate independently as a subject matter expert, ensuring effective execution of complex engineering tasks with minimal supervision
Analyze data trends and own facility-level metrics to minimize deviations and maximize gross margin
Qualification
Required
Bachelor's degree in a relevant field; Master's or Ph.D. preferred
Minimum 4 years of industrial experience in pharmaceutical or FDA-regulated manufacturing, with emphasis on sterile or aseptic processing
Proficiency in process validation PQ, PPQ, CPV, or APS
Strong knowledge of cGMP, EU regulations, USP standards, and sterile/aseptic process technologies
Demonstrated ability to author and review audit-ready, client-facing technical documentation
Excellent communication skills for interfacing across all organizational levels and during audits
Ability to mentor peers and influence site policies and practices
Flexibility for occasional off-shift, on-site support
Ability to sit or stand for extended periods and lift up to 40 lbs independently
Preferred
Master's or Ph.D
Benefits
Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
Life, AD&D, Short and Long Term Disability
401(k) with company tru-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.