Jubilant HollisterStier LLC
Weekday Senior Process Engineer
Jubilant HollisterStier LLC, Spokane, Washington, United States, 99254
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
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.
General:
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.
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.
Shift: Team members may choose between:
4 days at 10 hours per day,
Weekday shift:
Monday - Thursday
5 days at 8 hours per day,
Weekday Shift:
Monday - Friday
Compensation & Benefits: This is an
on-site,
full-time position located in Spokane, WA.
Hiring Wage:
$98,700.00 - $144,800
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
Each shift has defined core coverage:
Weekday Shift
( Shift 1 - no shift differential ): Core days are Monday through Thursday.
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
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:
JHS-TalentAcquisition@jubl.com
#J-18808-Ljbffr
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
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.
General:
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.
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.
Shift: Team members may choose between:
4 days at 10 hours per day,
Weekday shift:
Monday - Thursday
5 days at 8 hours per day,
Weekday Shift:
Monday - Friday
Compensation & Benefits: This is an
on-site,
full-time position located in Spokane, WA.
Hiring Wage:
$98,700.00 - $144,800
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
Each shift has defined core coverage:
Weekday Shift
( Shift 1 - no shift differential ): Core days are Monday through Thursday.
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
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:
JHS-TalentAcquisition@jubl.com
#J-18808-Ljbffr