Assembly Process Validation Engineer

작업 내용

About the job

SHL Medical AG is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems 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 since late 2018.

Taiwan has been SHL’s starting ground in our bid for global mobility in the fields of drug delivery and medical technology. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the delivery of modern precision medicine.

Job Overview

The Assembly Process Validation Engineer is responsible for defining and executing validation strategy and coordinating validation activities required to launch new automation assembly/inspection equipment into the production environment. The successful candidate will perform validation activities that include Assembly Equipment Qualification, 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.

Main Responsibilities

• Participate in design, development, commissioning and qualification of an automated manufacturing equipment/machine.
• Design and perform process characterization studies and experiments using statistical methods to develop new and/or improve existing assembly or inspection processes.
• Validate new automation processes, equipment and/or designs in collaboration with a diverse functional engineering team.
• Generate and sustain Verification/Validation protocols (I/OQ, PQ) and related technical documents to support the transfer of processes into production.
• Provide technical assessment and validation review/approval for engineering, process and standard operating procedure changes.
• Assist in failure investigations and root cause analyses as they relate to process performance.
• Involve in internal and external audit, and handle CAPA.

Required Skills & Qualifications

• Bachelor’s degree in Mechanical Engineering, Materials Engineering, Medical Device Engineering with mechanical emphasis, electrical Engineering, automotive engineering or related field.
• A minimum of 2+ years engineering experience in medical device or other regulated industry.
• Prior experience in medical device assembly process development.
• Quality Management System experience.
• Experience with planning and executing appropriate Measurement System Analysis; including Gage R&R, to establish test method suitability
• 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).
• Strong data analysis skills utilizing software such as Minitab.
• 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)
• Experience developing and executing IQ, OQ and PQ documentation for GMP equipment.
• Excellent verbal and written communication skills in bilingual (Mandarin and English).
• Skilled in the use of Microsoft Office Suite

We offer

• Competitive compensation package.
• 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.

Apply for this Job

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including CV and all other relevant documents.

For more information on SHL Medical, please visit our website: www.shl-medical.com

Is this not quite what you are looking for? Further interesting career opportunities can be found on our SHL Career page: www.shl-medical.com/careers

Please note: For this position we do not consider applications from recruitment agencies.