Senior Operations Specialist

Brooksource; Concord (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

A leading pharmaceutical manufacturing partner is seeking a Senior Operational Excellence Engineer to optimize visual inspection operations in an aseptic manufacturing environment. This role involves process standardization, operational readiness, and technical support, aiming for excellence in manufacturing processes with potential for full-time conversion. Ideal candidates will possess strong leadership skills and a background in a GMP-regulated setting.

Benefits

Medical insurance

Vision insurance

Qualifications

• Experience in GMP-regulated manufacturing.
• Strong technical expertise and leadership.
• Experience in visual inspection processes.

Responsibilities

• Lead implementation and improvement of visual inspection processes.
• Support start-up and operational readiness for inspection lines.
• Mentor team members in inspection best practices.

Skills

Process Standardization

Continuous Improvement

Technical Writing

Leadership

Communication

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

Microsoft Office

Job description

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| Engineering & Technology | Empowering Careers, Connecting Leaders | Industry 4.0

Senior Operational Excellence Engineer- Visual Inspection (Aseptic Manufacturing)

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing and Engineering

• Industries

  Pharmaceutical Manufacturing and Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

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