Jubilant Pharma Limited
Weekend Process Engineer I, II, & III
Jubilant Pharma Limited, Spokane, Washington, United States, 99254
Weekend Process Engineer I, II, & III
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Jubilant Pharma Limited
Jubilant HollisterStier LLC is a leading provider of pharmaceutical and biopharmaceutical services in Spokane, WA, specializing in allergenic extracts, sterile injectable vials, and lyophilized products.
Job Description
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 cGMPs, 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.
Qualifications
Process Engineer I
Bachelor’s of Arts or Science (Biology, Chemistry, Physics, or Engineering) required.
0 to 5 years related Pharmaceutical or FDA‑regulated Industry experience desired.
Master’s Degree counts as 2 years’ experience desired.
Project Management experience desired.
Statistical Analysis experience desired.
Lean Manufacturing Principles preferred.
Microsoft Office experience required.
Extended periods of sitting or standing required.
Ability to lift 40 lbs. unassisted required.
Process Engineer II (in addition to I)
2 to 5 years related Pharmaceutical or FDA‑regulated Industry experience required.
Supervisory or other Leadership experience desired.
Process Engineer III (in addition to II)
3‑7 years related Pharmaceutical or FDA‑regulated Industry experience required.
Supervisory or other Leadership experience desired.
Project Management required.
Shift
4 days at 10 hours per day – Weekend Shift: Friday‑Monday or Thursday‑Sunday.
5 days at 8 hours per day – Weekend Shift: Wednesday‑Sunday, Thursday‑Monday, or Friday‑Tuesday.
Compensation & Benefits
Process Engineer I: $77,969 – $99,000 (depending on experience) with promotion and annual raise opportunities.
Process Engineer II: $77,969 – $99,000 (depending on experience) with promotion and annual raise opportunities.
Process Engineer III: $79,500 – $116,600 (depending on experience) with promotion and annual raise opportunities.
Defined core coverage for each shift: Weekday Shift (Monday‑Thursday) and Weekend Shift (Friday‑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.
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.
#J-18808-Ljbffr
–
Jubilant Pharma Limited
Jubilant HollisterStier LLC is a leading provider of pharmaceutical and biopharmaceutical services in Spokane, WA, specializing in allergenic extracts, sterile injectable vials, and lyophilized products.
Job Description
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 cGMPs, 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.
Qualifications
Process Engineer I
Bachelor’s of Arts or Science (Biology, Chemistry, Physics, or Engineering) required.
0 to 5 years related Pharmaceutical or FDA‑regulated Industry experience desired.
Master’s Degree counts as 2 years’ experience desired.
Project Management experience desired.
Statistical Analysis experience desired.
Lean Manufacturing Principles preferred.
Microsoft Office experience required.
Extended periods of sitting or standing required.
Ability to lift 40 lbs. unassisted required.
Process Engineer II (in addition to I)
2 to 5 years related Pharmaceutical or FDA‑regulated Industry experience required.
Supervisory or other Leadership experience desired.
Process Engineer III (in addition to II)
3‑7 years related Pharmaceutical or FDA‑regulated Industry experience required.
Supervisory or other Leadership experience desired.
Project Management required.
Shift
4 days at 10 hours per day – Weekend Shift: Friday‑Monday or Thursday‑Sunday.
5 days at 8 hours per day – Weekend Shift: Wednesday‑Sunday, Thursday‑Monday, or Friday‑Tuesday.
Compensation & Benefits
Process Engineer I: $77,969 – $99,000 (depending on experience) with promotion and annual raise opportunities.
Process Engineer II: $77,969 – $99,000 (depending on experience) with promotion and annual raise opportunities.
Process Engineer III: $79,500 – $116,600 (depending on experience) with promotion and annual raise opportunities.
Defined core coverage for each shift: Weekday Shift (Monday‑Thursday) and Weekend Shift (Friday‑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.
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.
#J-18808-Ljbffr