Jubilant HollisterStier CMO
Weekend Senior Process Engineer
Jubilant HollisterStier CMO, Spokane, Washington, United States, 99254
Join to apply for the
Weekend Senior Process Engineer
role at
Jubilant HollisterStier CMO .
Jubilant HollisterStier LLC, Spokane’s Largest Manufacturing Company, is a well‑established member of the business community providing 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, targeting primarily the treatment of 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 pharmaceutical process engineering and technical transfer. This position manages large‑scale projects and multidisciplinary teams, provides technical direction for complex projects, and exhibits superior communication skills with all levels of employees. The engineer is responsible for refining department and site processes and providing leadership and guidance to others.
General Responsibilities
Design, optimise 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; utilise 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
Participate in or perform deviation investigation and evaluation of impact
Responsible for optimising gross profit margin and minimising deviation rate
Provide necessary reviews for regulatory and client audits and provide responses to audit observations
In‑depth understanding of cGMPs, European regulatory requirements, relevant USP chapters, and scientific principles associated with clean‑room operations and room classifications as they apply to media fills, sterilisation 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
Bachelor’s degree in Biology, Chemistry, Physics or Engineering (required)
5–10 years of related pharmaceutical experience or FDA‑regulated industry experience (required)
Supervisory or other leadership experience (required)
Master’s degree counts as 2 years experience
Microsoft Office experience (required)
Extended periods of sitting or standing (required)
Ability to lift 40 lbs unassisted (required)
Shift
4 days at 10 hours per day
Weekend Shift:
Friday‑Monday or Thursday‑Sunday
This is an
on‑site, full‑time
position located in Spokane, WA.
Hiring Wage
Hiring wage: $98,700.00 – $144,800.00 annually, depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees with longevity and outstanding performance in the role
Each shift has defined core coverage
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
EEO Statement Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Contact For assistance applying for a position, please contact our HR Department 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
Weekend Senior Process Engineer
role at
Jubilant HollisterStier CMO .
Jubilant HollisterStier LLC, Spokane’s Largest Manufacturing Company, is a well‑established member of the business community providing 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, targeting primarily the treatment of 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 pharmaceutical process engineering and technical transfer. This position manages large‑scale projects and multidisciplinary teams, provides technical direction for complex projects, and exhibits superior communication skills with all levels of employees. The engineer is responsible for refining department and site processes and providing leadership and guidance to others.
General Responsibilities
Design, optimise 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; utilise 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
Participate in or perform deviation investigation and evaluation of impact
Responsible for optimising gross profit margin and minimising deviation rate
Provide necessary reviews for regulatory and client audits and provide responses to audit observations
In‑depth understanding of cGMPs, European regulatory requirements, relevant USP chapters, and scientific principles associated with clean‑room operations and room classifications as they apply to media fills, sterilisation 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
Bachelor’s degree in Biology, Chemistry, Physics or Engineering (required)
5–10 years of related pharmaceutical experience or FDA‑regulated industry experience (required)
Supervisory or other leadership experience (required)
Master’s degree counts as 2 years experience
Microsoft Office experience (required)
Extended periods of sitting or standing (required)
Ability to lift 40 lbs unassisted (required)
Shift
4 days at 10 hours per day
Weekend Shift:
Friday‑Monday or Thursday‑Sunday
This is an
on‑site, full‑time
position located in Spokane, WA.
Hiring Wage
Hiring wage: $98,700.00 – $144,800.00 annually, depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees with longevity and outstanding performance in the role
Each shift has defined core coverage
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
EEO Statement Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Contact For assistance applying for a position, please contact our HR Department 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