Summary: The Manufacturing Engineer will be responsible for design, planning and implementation of validated manufacturing systems, equipment and facilities improvements within an FDA / cGMP / OTC environment. The ideal candidate will have working knowledge of mixing, compounding, filling and secondary packaging process and equipment. In addition, a proven track record of continuous improvement activities as a facilitator / leader in a cross functional team atmosphere. This position requires a hands-on approach and supports cross functional activities within the entire organization including but not limited to: Production, NPD, Quality, Validation, Purchasing, Safety Facilities and Logistics. This position is required to be onsite full time.
Roles and Responsibilities:
Support new product development and launches from a Manufacturing/Process Engineering perspective:
Manufacturing Feasibility
Process Flow
New Equipment design & purchase
Equipment standards / vendor scorecard development
Process Instructions, training, labor evaluations and costing
Equipment validation support (IQ/OQ/PQ)
Line balance & optimization
Component specifications / standards
Continuous Improvement
Prioritize Department opportunities
Propose and justify capital improvements
Implement methods and line balance improvements
Lead cross functional improvement initiatives
Provide & implement cost savings ideas (qty tbd each year)
Component specification development and print creation.
Support Equipment improvement activities from Maintenance and Production.
Train Production and Technical support on applicable equipment/processes.
Capital expenditure support regarding scope, design, justification, budgeting, & implementation.
Investigate and resolve day-to-day manufacturing engineering related issues.
Production floor issues (supporting maintenance)
Supplier quality issues
Recommend and implement layout improvements for better material flow.
Support safety related improvements related to process/equipment.
Other duties/projects as assigned by supervisor.
Qualifications and Requirements:
4 yr Manufacturing, Mechanical, or Process Engineer degree and five (5) or more years of applicable experience
Demonstrated Continuous Improvement project experience as a leader and facilitator
Excellent communication skills, both written and verbal
Proficient in Microsoft Office applications, including Word, Excel, PPT
Project management experience team facilitator
Problem solving experience or training (8D, Six Sigma, DOE, SPC)