Job Description

Senior Operational Excellence Engineer- Visual Inspection (Aseptic Manufacturing)

Location: Charlotte Metro Area (on-site)

Engagement: 15-month contracting engagement with potential for full-time conversion

Partner: Brooksource Engineering Services supporting a leading pharmaceutical manufacturing partner

About the Role

Brooksource Engineering Services is seeking a Senior Operational Excellence Engineer to support visual inspection operations in an aseptic pharmaceutical manufacturing environment. This role is part of a high-performing team focused on operational readiness, process standardization, and continuous improvement across multiple sites. The ideal candidate will bring deep technical expertise, strong leadership, and a passion for driving excellence in sterile manufacturing environments.

Key Responsibilities

Visual Inspection Process Optimization

• Lead the implementation and continuous improvement of visual inspection processes to ensure compliance, efficiency, and product quality.
• Develop and standardize visual inspection procedures, including manual and automated inspection methods.
• Identify and resolve inspection-related batch challenges, such as false rejects, misclassifications, or equipment inconsistencies.
• Create and maintain standard work documents, process maps, and training materials specific to visual inspection operations.

Operational Readiness & Start-Up Support

• Support the start-up and ramp-up of visual inspection lines, ensuring readiness of equipment, personnel, and documentation.
• Collaborate with engineering and quality teams to validate inspection systems and ensure readiness for routine production.
• Assist in prioritizing tasks and removing obstacles during the transition from project to operational phases.

Technical Support & Team Development

• Provide subject matter expertise on visual inspection best practices, including defect classification, lighting, and ergonomic setup.
• Mentor and coach inspection operators and process team members to build capability and ensure consistent execution.
• Support deviation investigations, change controls, and continuous improvement initiatives related to inspection processes.

Performance Monitoring & Metrics

• Define and track key performance indicators (KPIs) for visual inspection, such as defect rates, false reject rates, and throughput.
• Analyze inspection data to identify trends, root causes, and opportunities for improvement.
• Collaborate with quality and operations teams to address human errors and improve inspection accuracy.

Cross-Functional Collaboration

• Act as a liaison between site operations, engineering, and quality assurance to align inspection strategies and resolve issues.
• Support inspection readiness for regulatory audits and internal reviews.
• Share best practices and lessons learned across sites to drive consistency and excellence in visual inspection.

Qualifications

Basic Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience).
• Demonstrated experience in a GMP-regulated manufacturing environment.
• Proficiency with Microsoft Office and digital documentation systems.
• Strong communication, technical writing, and interpersonal skills.
• Experience mentoring, coaching, and providing feedback.

Preferred Qualifications

• Experience in Production, Quality Control, Quality Assurance, Technical Services, or Engineering.
• Knowledge of cGMPs and aseptic processing.
• Six Sigma Green Belt or Black Belt certification.
• Experience supporting operational readiness or start-up in parenteral manufacturing.

Additional Information

• Travel up to 30–50% may be required to support other sites.
• Flexibility to respond to operational issues outside of core business hours.
• Must be comfortable working in environments with potential allergen exposure.

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