Process Engineer IV, MSAT (Visual Inspection)
About The Position
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. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. 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. This includes feasibility evaluations, design, execution, and documentation of engineering studies, component specification and evaluation, and all other activities required to support delivery of a complete, validated process to manufacturing. Individuals in this role work closely with Validation, PMO, Supply Chain, Operations, Quality, and technical experts performing transfers to the site to ensure process implementation to commercial manufacturing follows project timelines and corporate standards. This posting is for a Visual Inspection Technical Lead (Automated and Manual).
Requirements
- Significant experience supporting manufacturing operations in a regulated or cGMP environment
- Demonstrated experience in visual inspection processes, automated vision systems, and process validation or technology transfer in pharmaceuticals or a comparable GMP environment
- Experience identifying, justifying, implementing, and testing process improvements in a cGMP environment
- Established track record as a technical SME in visual or process engineering
Nice To Haves
- 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
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
- Serve as site SME for visual inspection equipment and processes
- Lead continuous improvement efforts including changeover reduction, yield improvements, OEE improvements, maintenance reliability, and waste reduction for automated inspection equipment
- Define success criteria for technology transfer and process validation; ensure processes are capable prior to handoff to Manufacturing
- Generate URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports
- Perform and maintain risk management activities for new and existing processes and equipment
- Lead process validation activities required as a result of changes to validated manufacturing processes
- Participate in annual product reviews and biennial critical systems reviews
- 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
- Coordinate equipment data, capabilities, utilization, efficiencies, and lifecycle management
- 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
- Identify technical training needs for Operations, Engineering, and Maintenance
- Provide on-call support as required
- Serve as key technical contact during regulatory inspections
Benefits
- Relocation Assistance Offered
- annual cash bonus program
- 401(k) plan with a generous company match
- healthcare (including medical, dental and vision)
- family building benefits
- life and disability insurance
- paid vacation
- paid holidays
- other paid leaves of absence
- tuition reimbursement
- support for caregiving needs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
