Process Engineer

6 days ago


Chepstow, United Kingdom IntaPeople Full time

**Responsibilities**:
Transfer products to manufacturing
Ensure production lines are actively supported and any process improvements identified
Product and process Validation and Verification - including IQ/OQ/PQ, DOE and TMQs
PFMEA, MVP, Process flow, manufacturing plan, manufacturing instructions, manufacturing travellers & packaging processes
Design of jigs and fixtures using SolidWorks
Manufacturing of devices containing small parts and low volume manufacturing
Identify process problems and non-conformance’s in manufacturing processes and develop corrective actions
Define and perform maintenance and calibration procedures
Drive continuous and process improvements
Review procedures for accuracy and make updates using a Document Change Order to reflect process changes, and develop production procedures, standard operating procedures testing and inspection and drawings
Participate in New Product Development teams to establish quality standards for new products and create process procedures, specifications and work instructions as needed and support new product launches
Implement GMP (Good Manufacturing Practices) & GDP (Good Documentation Practice) throughout manufacturing
Coordinate the training of Manufacturing Operators and act as a mentor and technical resource
Development of manufacturing and verification of jigs and fixtures
Experience/Skills:
Experienced Process/Manufacturing Engineer
Experience within a highly regulated environment
Strong experience with product and process Validation and Verification - including IQ/OQ/PQ, DOE and TMQs.
Expertise with statistical process control (SPC, CPK’s etc.)
Excellent engineering and root cause analysis problems solving skills
Familiar with PFMEA, MVP, Process flow, manufacturing plan, manufacturing instructions, manufacturing travellers & packaging processes
SolidWorks experience


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