Process Engineer IV, MSAT (Visual Inspection)

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.

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. 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)

Key Responsibilities

Visual Inspection

• 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

Technology Transfer & Validation

• 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

Change Control & Investigations

• 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

Asset & Project Management

• 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

Operations Support

• Identify technical training needs for Operations, Engineering, and Maintenance
• Provide on-call support as required
• Serve as key technical contact during regulatory inspections

Minimum Qualifications

• 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

Preferred Qualifications

• 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:
Specific visual skills (i.e., extensive reading or computer use, normal color vision, depth perception, or visual acuity)

Specific hearing requirements - Interpreting sounds and associated meanings at volume levels consistent with interpersonal or group conversations; interpreting letters and numbers when viewed on a computer screen, monitor, reports and other documents.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.