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.
- 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%).
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.
Location: Spokane, WA - On Site, Full-TimeShift: Monday-Friday 5x8hrRelocation AvailableCompensation & Benefits That Start on Day One - Because Your Well Being Matters Hiring Wage: Hiring Wage:
$98,700.00 - $157,900annually depending on experience, with opportunity for growth, promotion and annual raises with opportunities for growth, promotion, and annual raises.
At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.
Starting on your first day, you receive:- Medical, Dental & Vision coverage
- Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
- Life & AD&D Insurance
- Short-Term & Long-Term Disability Insurance
- Employee Assistance Program
Unlock Your PotentialIf you're seeking a dynamic and rewarding career, we welcome your application today. Apply online:
Careers - Jubilant HollisterStier
