Qualifications:
Job Summary:
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. This position is for 1st shift (8am-4:30pm).
The Individual
Bachelors Degree required; Bachelors 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.