Assembly Process Validation Engineer

仕事内容

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems for the past 30 years with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland with sites in Sweden, Taiwan, and the Unites States.

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 Performance Qualification of an integrated manufacturing system across the entire validation lifecycle from Plan to Retire. Work with a cross functional team to support manufacturing capacity expansion projects.

Your Responsibilities

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

· Generate and sustain Verification/Validation protocols (IQ, OQ, PQ) 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 equipment, assembly process and standard operating procedure changes.

· Participate in design, development, commissioning and qualification of an automated manufacturing equipment/machine.

· Assist in failure investigations and root cause analyses as they relate to process performance.

· Involve in internal and external audit.

Your qualification

[Required]

· 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 in bilingual (Mandarin and English).

[Preferred]

· Strong 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).

· Experience developing and executing IQ, OQ and PQ documentation for GMP equipment.

· Experience with equivalent test, root cause analysis, process engineering, failure investigations, measurement system analysis and automated assembly equipment.

· Common risk management techniques (etc. FMEA, Fault-tree analysis)

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.