Overview
Skills
Job Details
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.