OPEX Quality Engineer II

Aerospace, shipbuilding, other transport equipment, Automotive, Electrical, optical, Engineering
Not specified
Contract type:
Full time
Salary description:
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Start Date:
Renaissance LLC
Job Ref:

Renaissance LLC

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.


The Operational Excellence Quality Engineer II will be responsible for driving business transformation in the laboratory areas through the implementation of Operational Excellence tools and culture.


• Define, implement, and refine continuous improvement initiatives as an internal coach and change agent with specific focus on our laboratories (analytical, microbiology, spray)
• Operate with a sense of urgency to provide tangible improvements in needed areas through lean laboratories and six sigma best practices
• Communicate effectively with numerous stakeholders to foster a sense of collaborative improvement
• Educate stakeholders at front line and supervisory levels in the tools and principles of Operational Excellence including, but not limited to Waste Identification, 5S, Structured Problem Solving, Tiered Communications, SMED, Value Stream Mapping, OPEX Leadership, and Maintenance Excellence
• Analyze and identify opportunities in process / area performance data (e.g., bottleneck analysis, level loading, process mapping)
• Function as a coordinator and facilitator for OPEX projects
• Develop detailed OPEX project plans for multidisciplinary teams in targeted areas across functions and groups
• Support OPEX events / general problem solving (including but not limited to Kaizen events, operator and supervisor coaching, training, tier system rollouts)
• Provide support for CAPAs (Corrective and Preventive Actions), investigations, and change controls if needed
• Identify areas for improvement in existing front-line operations and processes
• Provide coaching to shop floor employees and supervisors through Gemba Walks, 1:1 discussions, and group interactions
• Help maintain reliable and safe manufacturing systems while improving production rates, efficiencies, yields, reducing overall operating costs and increasing Quality
• Aid in training of operations and maintenance personnel
• Effectively interact with other groups / functions including Quality, Engineering, and Validation
• Perform other duties and responsibilities as assigned


Bachelor's degree required

Minimum seven years of experience in a pharmaceutical manufacturing environment with a minimum three years of GMP-related Quality Assurance / Quality Control experience

Experience with Corrective and Preventive Action creation, tracking, and closure

Experience with lean concepts and a desire to learn

Excellent communication, listening, collaboration, and influencing skills

Closing Date:
Contact Details:
Renaissance LLC
Contact: N/A

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