Process Engineer, Sr.

Stryker Corporation; Spokane, Northern (WA, KY); Hybrid; Confidential; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

FSA/HSA

Life Insurance

AD&D

Disability Insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA is seeking a Senior Process Engineer to lead pharmaceutical process engineering and technical transfer. You will manage large-scale projects, guide multi-disciplinary teams, and provide technical direction to ensure robust, compliant manufacturing processes.

The role requires refining site processes, overseeing CPPs/CQAs, and supporting regulatory audits with strong communication across all levels. On-site work with travel <10% is expected.

Qualifications

• Bachelor's in biology, chemistry, physics, or engineering is required.
• 5–10 years related pharmaceutical or FDA-regulated experience.
• Supervisory or other leadership experience required.
• Project management experience required.

Responsibilities

• Design, optimize and implement site manufacturing processes to improve efficiency, quality and sustainability.
• Oversee and assess existing processes and workflows.
• Establish and track process metrics to monitor stability and identify improvements.
• Technical transfer of new products from internal and external clients.
• Own product processes from initial quote to retirement.
• Prepare and review data and reports for quality and regulatory audits.
• Lead CAPA implementations and deviation investigations.

Skills

Leadership

Project management

Lean manufacturing

Statistical analysis

Microsoft Office

Education

Bachelor's degree in Biology, Chemistry, Physics, or Engineering

Job description

Join a Leader in Pharmaceutical Manufacturing - And Build What's Next

As Spokane's Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

For the Builders, Innovators, and Doers - This Is Your Place

If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you'll feel at home here. At Jubilant HollisterStier, your ideas matter - and your impact is felt globally.

Why builders choose us:

• Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide.
• Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well-being shouldn't have a waiting period.
• A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.
• A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution.
• A stable industry leader: Backed by Jubilant Pharma, we pair long term stability with forward looking innovation.

If you want to build something meaningful with a team that values your drive, skills, and ideas - you belong here.

Job Description:

The Senior Process Engineer provides expertise primarily in the areas of pharmaceutical process engineering and technical transfer. This position will manage large scale projects and multi-disciplinary teams. The process engineer will also provide technical direction for complex projects and exhibit superior communication skills with all levels of employees. The individual will be responsible for refining department and site processes and provide leadership and guidance to others.

• Design, optimize and implement site manufacturing processes to improve efficiency, quality and sustainability.
• Oversee and assess existing processes and workflows.
• Establish and track process metrics to monitor process stability and discover areas for improvement.
• Technical Transfer of new products from both internal and external clients.
• Ownership of product process from initial quote to product retirement.
• Evaluate incoming processes for robustness, efficiency and fit within JHS-Spokane.
• Perform appropriate development work to define CPPs and CQAs to allow strong execution upon transfer to Manufacturing.
• Author validation study documents that demonstrate manufacturing processes are capable of consistently making acceptable product.
• Develop and execute validation studies to test and qualify new and improved manufacturing processes.
• Troubleshooting, oversight and/or sampling of events within Manufacturing will require occasional off-shift at-location support.
• Generate reports summarizing results of studies to document data collected; utilize data obtained to qualify site processes.
• Review data summaries generated by other departments, assess the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective action measures are implemented when required/warranted.
• Participate in or perform deviation investigation and evaluation of impact.
• Implement effective CAPAs.
• Responsible for optimizing gross profit margin and minimizing deviation rate.
• Provide necessary reviews for regulatory and client audits and provide responses to audit observations.
• In-depth understanding of cGMP's, European regulatory requirements, relevant USP chapters, and scientific principles associated with clean room operations and room classifications as they apply to media fills, sterilization and depyrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control.
• Minimal travel (< 10%).

Level Specific:

• Expected to perform job functions autonomously and effectively.
• Expected to be an authority in pertinent scientific principles and applicable existing and new guidance.
• Expected to be an authority on technical aspects of site processes.
• Expected to provide leadership and guidance to others on these topics, as well as update and improve site practices and policies accordingly.

Qualifications:

• A Bachelor's of Arts or Science with a major in Biology, Chemistry, Physics, or Engineering is required.
• 5-10 years related Pharmaceutical experience or FDA regulated Industry Experience required.
• Supervisory or other Leadership Experience required.
• Project Management experience required.
• Master's Degree counts as 2 yrs experience.
• Statistical Analysis desired.
• Lean Manufacturing Principles desired.
• Microsoft Office experience required.
• Extended periods of sitting or standing required.
• Ability to lift 40 lbs. unassisted required.

Location: Spokane, WA - On Site, Full-Time

Shift: Monday-Friday 5x8hr

Relocation Available

Compensation & Benefits That Start on Day One - Because Your Well Being Matters

Hiring Wage: $98,700.00 - $157,900 annually depending on experience, with opportunity for growth, promotion and annual raises with opportunities for growth, promotion, and annual raises.

At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.

Starting on your first day, you receive:

• Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program

Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Our Promise: Caring, Sharing, Growing

We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society.