Process Engineering - Weekend Shift

Jubilant HollisterStier LLC, Spokane's Largest Manufacturing Company
Jubilant HollisterStier LLC, Spokane's Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing
We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions through growth, cost effectiveness and wise investment of resources.

Job Description
The Process Engineer III provides expertise primarily in the area of pharmaceutical process engineering and technical transfer. This position will effectively manage large‑scale projects and multi‑disciplinary project teams, provide technical direction for complex projects, exhibit superior communication skills with all levels of employees, and lead 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 (
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

Qualifications

A Bachelor of Arts or Science with a major in Biology, Chemistry, Physics, or Engineering is required

3-7 years related Pharmaceutical experience or FDA regulated Industry Experience required

Supervisory or other Leadership Experience desired

Master's Degree counts as 2 yrs experience desired

Project Management experience desired

Statistical Analysis experience desired

Lean Manufacturing Principles experience desired

Functional expert Project Management required

Functional expert Microsoft Office required

Extended periods of sitting or standing required

Ability to lift 40 lbs. unassisted required

Work in classified/aseptic areas required

Work in confined spaces required

Potential exposure to allergens required

Shift

4 days at 10 hours per day

Weekend Shift: Friday-Monday or Thursday-Sunday

5 day sat 8 hours per day

Weekend Shift: Wednesday-Sunday OR Thursday - Monday OR Friday-Tuesday

Compensation & Benefits
This is an on‑site , full‑time position located in Spokane, WA.

Hiring Wage: $79,500.00 - $127,200 annually depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role

Shift Differential pay is available for this position, and is determined by hours worked on selected shift

Weekend Shift ( weekend days - shift diff 7.5% ): Core days are Friday through Sunday

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

Jubilant HollisterStier is 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.

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