Jubilant HollisterStier CMO
Weekday Process Engineer I, II, & III
Jubilant HollisterStier CMO, Spokane, Washington, United States, 99254
Weekday Process Engineer I, II, & III
Join to apply for the Weekday Process Engineer I, II, & III role at Jubilant HollisterStier CMO.
Jubilant HollisterStier LLC is a well‑established member of the business community in Spokane, Washington, providing a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products.
Our Promise: Caring, Sharing, Growing
Job Description The Process Engineer I/II/III provides ownership and focus for pharmaceutical processes and technical transfers at Jubilant HollisterStier. This position will engage in and manage projects and multidisciplinary teams with direct supervision.
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
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 dehydrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control.
Minimal travel ( Process Engineer I
Expected to perform job functions with direct supervision. This person must be capable of working independently; however, will not be expected to perform autonomously.
Expected to be knowledgeable in pertinent scientific principles and capable of researching applicable guidance, obtaining understanding, and maintaining awareness.
Expected to obtain subject matter expertise on technical aspects of site processes.
Process Engineer II
Expected to perform job functions autonomously with leadership oversight provided to increase effectiveness.
Expected to be knowledgeable in pertinent scientific principles and of applicable existing and new guidance.
Expected to obtain and maintain subject matter expertise on technical aspects of site processes.
Process Engineer III
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 Process Engineer I
A Bachelor’s of Arts or Science with a major in Biology, Chemistry, Physics, or Engineering is required.
0 to 5 year(s) related Pharmaceutical experience or FDA regulated Industry Experience is desired
Master’s Degree counts as 2 years’ experience desired
Microsoft Office experience required
Extended periods of sitting or standing required
Ability to lift 40 lbs. unassisted required
Process Engineer II
2 to 5 year(s) related Pharmaceutical experience or FDA regulated Industry Experience required
Supervisory or other Leadership Experience desired
Process Engineer III
3-7 years related Pharmaceutical experience or FDA regulated Industry Experience required
Supervisory or other Leadership Experience desired
Project Management required.
Shift & Location
4 days at 10 hours per day
Weekday shift: Monday – Thursday
Weekday Shift: Monday - Friday
This is an on‑site, full‑time position located in Spokane, WA.
Hiring Wage
Process Engineer I: $77,969–$99,000
Process Engineer II: $77,969–$99,000
Process Engineer III: $79,500–$116,600
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
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Manufacturing and Engineering
Industry Pharmaceutical Manufacturing
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.
If you require assistance applying for a position, please contact our Talent Acquisition team at JHS‑TalentAcquisition@jubl.com.
Unlock your potential with Jubilant HollisterStier! If you’re seeking a dynamic and rewarding career, we welcome your application today!
https://jubilantcareer.jubl.com/
#J-18808-Ljbffr
Jubilant HollisterStier LLC is a well‑established member of the business community in Spokane, Washington, providing a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products.
Our Promise: Caring, Sharing, Growing
Job Description The Process Engineer I/II/III provides ownership and focus for pharmaceutical processes and technical transfers at Jubilant HollisterStier. This position will engage in and manage projects and multidisciplinary teams with direct supervision.
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
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 dehydrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control.
Minimal travel ( Process Engineer I
Expected to perform job functions with direct supervision. This person must be capable of working independently; however, will not be expected to perform autonomously.
Expected to be knowledgeable in pertinent scientific principles and capable of researching applicable guidance, obtaining understanding, and maintaining awareness.
Expected to obtain subject matter expertise on technical aspects of site processes.
Process Engineer II
Expected to perform job functions autonomously with leadership oversight provided to increase effectiveness.
Expected to be knowledgeable in pertinent scientific principles and of applicable existing and new guidance.
Expected to obtain and maintain subject matter expertise on technical aspects of site processes.
Process Engineer III
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 Process Engineer I
A Bachelor’s of Arts or Science with a major in Biology, Chemistry, Physics, or Engineering is required.
0 to 5 year(s) related Pharmaceutical experience or FDA regulated Industry Experience is desired
Master’s Degree counts as 2 years’ experience desired
Microsoft Office experience required
Extended periods of sitting or standing required
Ability to lift 40 lbs. unassisted required
Process Engineer II
2 to 5 year(s) related Pharmaceutical experience or FDA regulated Industry Experience required
Supervisory or other Leadership Experience desired
Process Engineer III
3-7 years related Pharmaceutical experience or FDA regulated Industry Experience required
Supervisory or other Leadership Experience desired
Project Management required.
Shift & Location
4 days at 10 hours per day
Weekday shift: Monday – Thursday
Weekday Shift: Monday - Friday
This is an on‑site, full‑time position located in Spokane, WA.
Hiring Wage
Process Engineer I: $77,969–$99,000
Process Engineer II: $77,969–$99,000
Process Engineer III: $79,500–$116,600
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
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Manufacturing and Engineering
Industry Pharmaceutical Manufacturing
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.
If you require assistance applying for a position, please contact our Talent Acquisition team at JHS‑TalentAcquisition@jubl.com.
Unlock your potential with Jubilant HollisterStier! If you’re seeking a dynamic and rewarding career, we welcome your application today!
https://jubilantcareer.jubl.com/
#J-18808-Ljbffr