PDMP - Molding Process Validation Engineer

Job Overview

The Validation Engineer is responsible for validating all equipment and injection molding tool used in injection molding related process, including resin incoming inspection equipment, measurement equipment, etc.

Main Responsibilities

• Responsible for following all applicable SOPs and Work Instructions at all times.
• Responsible for following the principle of GMP to the best of their ability at all times.
• Evaluate the necessity of validation activity and design/discuss validation scale/approach according to the validation policy in SHL with internal and external stakeholders/vendors.
• Generate validation plan and reports.
• Establish validation agenda and arrange validation runs, testing, and metrology.
• Implement tool or equipment/process validation activities with all supporting units and collect the related test results.
• Participate in deviation handling led by investigation leader and come up with action plans and proceed further validation activities accordingly.
• Provide audit materials of validation execution level.
• Able to introduce validation concepts/designed approach to internal/external auditors or customers.
• Carry out other duties as assigned.
• Business travel is required.

Skills & Qualifications

• Bachelor’s degree in Mechanical Engineering, Materials Engineering, Medical Device Engineering with mechanical emphasis, Electrical Engineering, automotive engineering or related field.
• Strong data analysis skills utilizing software such as Minitab.
• Skilled in the use of Microsoft Office Suite
• Good verbal and written communication skills in English
• Working knowledge of GMP, ISO, and FDA rules and regulatory requirements (etc. ISO 13485, ISO 14971, ISO 11608 , 21 CFR Part 11, 21 CFR 820 and FDA GMPs) is a plus.
• Experience in developing and executing IQ, OQ and PQ documentation for GMP equipment is preferred.
• Common risk management techniques (etc. FMEA, Fault-tree analysis) is a plus.
• Experienced with equivalent test, process engineering, failure investigations, root cause analysis, measurement system analysis and automated assembly equipment is preferred
• Able to introduce validation concept/approach/strategy to internal/external auditors or customers