Process Engineer IV, MSAT (Visual Inspection)

Resilience; Port Union (OH); On-site; USD 110,000 - 158,750; Full time

Benefits offered by this job

Annual cash bonus

401(k) plan with company match

Health, dental and vision coverage

Tuition reimbursement

Job summary

Resilience in Port Union is searching for a Visual Inspection Technical Lead to manage visual inspection processes in manufacturing. The role includes defining procedures, leading improvements, and ensuring compliance with regulatory standards.

Candidates should possess a Bachelor's degree in Engineering and significant cGMP experience. The position offers a competitive salary range of $110,000 to $158,750, along with benefits such as health coverage, retirement plans, and paid time off.

Qualifications

• Significant experience supporting manufacturing operations in a cGMP environment.
• Demonstrated experience in visual inspection processes and automated vision systems.
• Established track record as a technical SME in visual or process engineering.

Responsibilities

• Own all MSAT responsibilities related to visual inspection of filled container closures.
• Lead continuous improvement efforts for automated inspection equipment.
• Initiate deviations and lead technical investigations.

Skills

Visual inspection processes

Automated vision systems

Process validation

Project management

Six Sigma skills

LEAN manufacturing

Education

Bachelor's degree in Engineering or a related technical discipline

Tools

Quality management systems

Job description

Relocation Assistance Offered

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

Additional Conditions

Specific visual skills (e.g., extensive reading or computer use, normal color vision, depth perception, or visual acuity) are required to perform the essential functions of this job.

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.

Contact for Sponsorship

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

Equal Employment Opportunity

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.

Benefits

The target base pay hiring range for this position is $110,000.00 - $158,750.00 per year, dependent on experience, qualifications, and location. Additional benefits include annual cash bonus, 401(k) plan with company match, health, dental and vision coverage, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement, and support for caregiving needs.