Jubilant HollisterStier LLC
Weekend Shift Process Engineer I, II, III, & Sr.
Jubilant HollisterStier LLC, Spokane, Washington, United States, 99254
Overview
Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides 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. 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 weekend shift Process Engineer I/II/III/Sr.
provides ownership and focus for pharmaceutical processes and technical transfers at Jubilant HollisterStier. This position will engage in and manage projects and multi-disciplinary teams with direct supervision. The process engineer will also contribute technical direction for complex projects and exhibit clear communication skills with all levels of employees.
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 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%)
Process Engineer Levels
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:
In addition to the above, expected to perform job functions autonomously with leadership oversight provided to increase effectiveness. Expected to be knowledgeable in pertinent scientific principles and applicable existing and new guidance. Expected to obtain and maintain subject matter expertise on technical aspects of site processes. Supervisory or other Leadership Experience required.
Process Engineer III:
In addition to the above, 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. Provide leadership and guidance to others on these topics, as well as update and improve site practices and policies accordingly. Supervisory or other Leadership Experience required. Project Management required.
Senior Process Engineer:
In addition to the above, expected to provide leadership and guidance to others on these topics, as well as update and improve site practices and policies accordingly. Supervisory or other Leadership Experience required. Project Management required.
Shift Shift:
Weekend 12hr days: Friday - Sunday with alternating Thursday every other week 5:30am - 5:30pm with opportunity for hybrid hours. This shift provides a 10% shift differential on top of base compensation.
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 yrs experience
Project Management
Statistical Analysis
Lean Manufacturing Principles
Process Engineer II:
2 to 5 year(s) related Pharmaceutical experience or FDA regulated Industry Experience required
Supervisory or other Leadership Experience required
Process Engineer III:
3-7 years related Pharmaceutical experience or FDA regulated Industry Experience required
Supervisory or other Leadership Experience required
Project Management required.
Senior Process Engineer:
5-10 years related Pharmaceutical experience or FDA regulated Industry Experience required
Supervisory or other Leadership Experience required
Project Management required.
Compensation & Benefits This is an
on-site , full-time position located in Spokane, WA.
Hiring Wage:
Process Engineer I: $77,969- $85,800
Process Engineer II: $77,969- $99,000
Process Engineer III: $79,500-$116,600
Senior Process Engineer: $98,700-$144,800
depending on experience, with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package.
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.
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
Optional Benefits:
Voluntary Life and AD&D for employee & family
Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
Pet Insurance
ID Theft Protection
Perk Spot Discount Program
Note: Some formatting and links have been adjusted for accessibility.
Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!
https://jubilantcareer.jubl.com/
*Please click on the Spokane, Wa. Link*
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 HR Department at:
Human.Resources@jubl.com
#J-18808-Ljbffr
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 weekend shift Process Engineer I/II/III/Sr.
provides ownership and focus for pharmaceutical processes and technical transfers at Jubilant HollisterStier. This position will engage in and manage projects and multi-disciplinary teams with direct supervision. The process engineer will also contribute technical direction for complex projects and exhibit clear communication skills with all levels of employees.
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 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%)
Process Engineer Levels
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:
In addition to the above, expected to perform job functions autonomously with leadership oversight provided to increase effectiveness. Expected to be knowledgeable in pertinent scientific principles and applicable existing and new guidance. Expected to obtain and maintain subject matter expertise on technical aspects of site processes. Supervisory or other Leadership Experience required.
Process Engineer III:
In addition to the above, 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. Provide leadership and guidance to others on these topics, as well as update and improve site practices and policies accordingly. Supervisory or other Leadership Experience required. Project Management required.
Senior Process Engineer:
In addition to the above, expected to provide leadership and guidance to others on these topics, as well as update and improve site practices and policies accordingly. Supervisory or other Leadership Experience required. Project Management required.
Shift Shift:
Weekend 12hr days: Friday - Sunday with alternating Thursday every other week 5:30am - 5:30pm with opportunity for hybrid hours. This shift provides a 10% shift differential on top of base compensation.
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 yrs experience
Project Management
Statistical Analysis
Lean Manufacturing Principles
Process Engineer II:
2 to 5 year(s) related Pharmaceutical experience or FDA regulated Industry Experience required
Supervisory or other Leadership Experience required
Process Engineer III:
3-7 years related Pharmaceutical experience or FDA regulated Industry Experience required
Supervisory or other Leadership Experience required
Project Management required.
Senior Process Engineer:
5-10 years related Pharmaceutical experience or FDA regulated Industry Experience required
Supervisory or other Leadership Experience required
Project Management required.
Compensation & Benefits This is an
on-site , full-time position located in Spokane, WA.
Hiring Wage:
Process Engineer I: $77,969- $85,800
Process Engineer II: $77,969- $99,000
Process Engineer III: $79,500-$116,600
Senior Process Engineer: $98,700-$144,800
depending on experience, with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package.
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.
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
Optional Benefits:
Voluntary Life and AD&D for employee & family
Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
Pet Insurance
ID Theft Protection
Perk Spot Discount Program
Note: Some formatting and links have been adjusted for accessibility.
Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!
https://jubilantcareer.jubl.com/
*Please click on the Spokane, Wa. Link*
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 HR Department at:
Human.Resources@jubl.com
#J-18808-Ljbffr