Process Engineer III

Jubilant HollisterStier LLC; Spokane (WA); On-site; USD 79,500 - 127,200; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

401(k) with company match

Generous paid time off plan

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane is hiring a Process Engineer III to manage large-scale projects in pharmaceutical process engineering. This full-time on-site position requires a Bachelor's degree in a relevant field and 3-7 years of related industry experience. Responsibilities include designing and optimizing processes, overseeing technical transfers, and leading project teams. Competitive compensation of $79,500 - $127,200 annually based on experience, with a range of benefits offered including medical and 401(k) matching.

Qualifications

• 3-7 years related Pharmaceutical or FDA regulated industry experience required.
• Supervisory or Leadership Experience is desired.
• Master's Degree counts as 2 years experience.

Responsibilities

• Design, optimize and implement site manufacturing processes.
• Technical Transfer of new products from clients.
• Develop and execute validation studies for manufacturing processes.

Skills

Pharmaceutical experience

Statistical Analysis

Project Management

Microsoft Office

Lean Manufacturing Principles

Education

Bachelor of Arts or Science in Biology, Chemistry, Physics or Engineering

Job description

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 (<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

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.