Pharma/Manufacturing Process Engineer (1st Shift)(ONSITE)(No C2C/H1B)

Requirements:

• Bachelor s Degree required; Bachelor s Degree in Engineering in Maintenance & Reliability, Mechanical, Electrical, Process, Chemical or equivalent preferred
• Strong communication, intrapersonal and written skills.
• 3+ years of experience in medical device or pharmaceutical manufacturing
• 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.

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

• External Partners: Material Suppliers and Customers

Performs complex technical work including the design, troubleshooting and operation of structures, machines and systems in the labeling department. Additional responsibility includes leading a team of 4 labeling operators.

The Opportunity

As we continue to grow, we are seeking a Manufacturing Process Engineer. This position is responsible for providing leadership and technical support to the labeling department within Raritan manufacturing. The manufacturing process engineer will be an expert in their function, and must develop a deep understanding of the products, processes, equipment, and quality aspects. They will oversee the labeling of products on 3 P-I-L lines and will be responsible for all daily support functions such as problem solving, trouble shooting, training, and coaching. They will ensure all activities are executed according to detailed operational specifications within a cGMP environment, while working to enhance business objectives and operations performance through the identification and execution of process improvement projects.

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

• 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.