Operational Excellence Quality Engineer

　　Engineering

　　Ocean County, NJ, US

　　Added - 02/01/2024Apply for Job

　　Our Client, a leading contract development and manufacturing organization (CDMO) for pharmaceutical and biotech companies, is seeking a quality engineer to join their growing team. This is a great opportunity to contribute to the development and commercialization of innovative medicines, from early-stage development through final production.

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

　　Responsibilities:

　　• Define, implement, and refine continuous improvement initiatives as an internal coach and change agent

　　• 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

　　• Apply Lean principles and experience to support plant initiatives

　　• 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 and ownership 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, root cause analysis 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, Maintenance, MST, and Validation

　　• Perform other duties and responsibilities as assigned

　　• Manage medium and large projects

　　Qualifications:

　　Bachelor’s degree in Engineering or a related field

　　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, verbal, listening, collaboration, and influencing skills

　　Certified Six Sigma Green Belt (preferred)

　　We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.