Resilience
Process Engineer IV, MSAT (Visual Inspection)
USA - OH - West Chester
Work authorization required$110k-$159kDetected 39 days ago
Project ManagementSupply ChainProcess ImprovementProcurementGMPLean Manufacturing
About the role
- Relocation Assistance Offered A career at Resilience is more than just a job - it's an opportunity to change the future.
- Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made.
- For more information, please visit www.resilience.com The MSAT Process Engineer IV has responsibility for execution of technical aspects of product and/or process technology transfer to the site through successful completion of PPQ.
Responsibilities
- Own all MSAT responsibilities related to visual inspection of filled container closures (automated and manual)
- Define and maintain visual inspection centerlines, critical process parameters, material fit-for-use criteria, and operating procedures to ensure process capability
- Lead continuous improvement efforts including changeover reduction, yield improvements, OEE improvements, maintenance reliability, and waste reduction for automated inspection equipment
- Perform and maintain risk management activities for new and existing processes and equipment
- Initiate deviations and lead or facilitate technical investigations and impact assessments
- Identify, develop, and manage change controls to improve processes and address root causes
- Author, review, and approve SOPs, batch records, rework procedures, validation documents, and change requests
- Own user requirements for new asset procurement
- Develop project justifications and engineering proposals, including input to the capital planning process
- Maintain external technical relationships with equipment and material suppliers
Requirements
- Experience identifying, justifying, implementing, and testing process improvements in a cGMP environment
- Established track record as a technical SME in visual or process engineering
- Lead process validation activities required as a result of changes to validated manufacturing processes
Nice to have
- Bachelor's degree in Engineering or a related technical discipline
- Experience with both automated and manual visual inspection
- Project management experience, including leading equipment installation and qualification efforts
- Six Sigma or analytical troubleshooting skills
- Experience in a LEAN manufacturing environment
- Proficiency with quality management systems (deviations, change controls, CAPAs)
- Ability to coach and mentor peers
- This position may also include the following conditions:
Compensation
- Participate in annual product reviews and biennial critical systems reviews
- Our target base pay hiring range for this position is $110,000.00 - $158,750.00 per year.
Benefits
- Specific visual skills (i.e., extensive reading or computer use, normal color vision, depth perception, or visual acuity)
Equal opportunity
- Requests for reasonable accommodation can be made at any stage of the recruitment process.
Visa & Work Authorization
- Sponsorship or support for work authorization, including visas, is not available for this position.
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