Weekend Process Engineer I, II, & III
About The Position
TheProcess Engineer I/II/IIIprovides 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. 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%)
Requirements
- 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
- 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
- 2 to 5 year(s) related Pharmaceutical experience or FDA regulated Industry Experience required
- Supervisory or other Leadership Experience desired
- 3-7 years related Pharmaceutical experience or FDA regulated Industry Experience required
- Project Management required.
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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Industry
Chemical Manufacturing
Number of Employees
5,001-10,000 employees
