Manufacturing Engineer

Job Title: Manufacturing Process Engineer

Location: Raritan, NJ

Duration: 24+ Months Contract (possible extension of long term)

C2C is not allowed

Bachelor's Degree required; Bachelor's Degree in Engineering in Maintenance & Reliability, Mechanical, Electrical, Process, Chemical or equivalent preferred

• 3+ years of experience in medical device or pharmaceutical manufacturing preferred
• Experience using SAP is preferred
• Process Excellence experience preferred
• Proficient with using MS Office (Word, Excel, Outlook)
• Strong mechanical problem-solving ability and technical aptitude.
• Ability to work independently with limited supervision and work as part of a team
• Able to solve practical/complex problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to demonstrate flexibility and adaptability, as well as prioritize within a changing business environment
• Must pass vision acuity test for inspection of work in process and finished goods
• Ability to occasionally lift up to 40lbs.
• Strong communication, intrapersonal and written skills.

The Key Working Relationships

• Internal Partners: Planning, QA, QC Inspection, Quality Engineering, Warehouse personnel, Manufacturing and Facilities
• External Partners: Material Suppliers and Customers

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. The employee is required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms for extended periods of time. Is frequently required to communicate with coworkers. Ability to lift-up to 40lbs. Work with blood, blood products and chemicals. Periodic exposure to 2-8 C temperature controlled cold box during product transfer.

Responsibilities:

• Provides leadership to the labeling operators. First contact for labelers and labeling production issues.
• Communicates and provides feedback on operator performance
• Provides daily manufacturing floor support including problem solving, troubleshooting, training, and coaching
• Provides labeling line technical support (mechanical and vision system) on the Accraply 9000W labelers, Xyntek Vision systems, as well as Zebra thermal label printers.
• Recognizes potential for innovations/cost reductions. Leads process improvement projects through to implementation.
• Generates solutions to problems and reduces them to practices.
• Revises departmental batch traceability records and other procedures as required.
• Recognizes, opens, writes, and reviews non-conformances. Responsible for timely implementation of CAPAs as required.
• Tracks and trend process and business metrics for the department
• Supports new product or process implementations
• Ensures all processes and equipment are compliant with internal and external safety, environmental and quality regulations
• Ensure labeling operators are executing manufacturing or manufacturing-support processes according to standard operating procedures
• Actively leads/co-leads Kaizens and Gemba walks
• Demonstrates the ability to make quality decisions about labeling processes in the absence of management
• Acts as the liaison between Operations and Engineering
• Tracking and trending line downtime - reviews progress reports concerning status and downtime of machines and equipment and apprises Production Planner/Supervisor of delays
• Adheres to the safety code of Conduct & EHS policies and attends all required EHS training.
• Supports schedule adjustments to meet production, material receipt and shipping requirements.
• Uses ERP systems to perform material transactions/moves/quantities/cycle counts
• Uses purchasing systems to secure parts for production
• Demonstrates training progression and trains designated personnel on all levels of responsibility
• Wears the appropriate PPE when working in manufacturing and other working environments. Participates in hand-over/Shift Change meetings as required
• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, TUV, EPA and OSHA.
• Responsible for audit preparation and participation
• Occasionally, the employee will need to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms for extended periods of time.
• Occasionally work with blood, blood products and chemicals
• 90% of time spent on Manufacturing floor
• Perform other work-related duties as assigned.