[ PDAP ] Assembly Process Validation Engineer

Job Overview

The Assembly Process Validation Engineer is responsible for defining validation strategy and executing/coordinating validation activities required to launch new automation assembly equipment or assembly process into the production environment. The successful candidate will perform validation activities that include Assembly Equipment Qualification, and Process Validation of an integrated manufacturing system. Work with a cross functional team to introduce new manufacturing equipment, new process, or new technology to mass production.

Your Responsibilities

• Validate new assembly equipment and/or processes in collaboration with a diverse functional engineering team.

• Generate and sustain Verification/Validation protocols/reports (IQ, OQ, PQ, PV) and related technical documents to support the transfer of assembly equipment/process from development into mass production.

• Provide technical assessment and validation review/approval for changes regarding manufacturing equipment, assembly process and related standard operating procedures.

• Participate in design, development, commissioning, and qualification of automated manufacturing equipment.

• Assist in failure investigations and root cause analyses occurred during equipment qualification and process validation.

• Involve in the risk assessment (P-FMEA) of manufacturing equipment/process and provide input to the risk mitigation plan as validation engineer.

• Involve in internal and external audits.

Your qualification

• 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

• Excellent verbal and written communication skills (Mandarin and English).

• Experienced with equivalent test, process engineering, failure investigations, root cause analysis, measurement system analysis and automated assembly equipment is preferred.

• Common risk management techniques (etc. FMEA, Fault-tree analysis) is preferred.

• 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 a plus.

We offer

• Modern & variety of culture working environment with state-of-the-art facilities and technologies.

• Challenging assignments in a fast growing and innovative industry.

• Position in a dynamic, international team of highly skilled professionals.

• Various opportunities for personal and professional development within a global organization.