Senior Validation Control 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

A mid senior level Validation personnel who applies regulatory, compliance and engineering knowledge to set requirements related to medical device validation. The candidate ensures risk-based validation approach is implemented while maintaining compliance to external regulations including, but not limited to FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 11608 & ISO 14971.

Main Responsibilities

• Implement high level validation governance structure that’s enables lean risk-based validation approach and compliance to all related regulatory standards.
• Participate in project initiation and planning stages to ensure validation approach is clear and understood by all related parties.
• Ensure all functions adhere to validation requirements and standards during product development, engineering, validation and manufacturing stages.
• Review and approve the Master Validation plan for each project ensuring the criteria are aligned to customer, regulatory, quality and risk requirements.
• Collaborate with Risk Management and Quality personnel to ensure all critical to quality attributes are validated to the right level and sustenance plans are set in place for mass manufacturing.
• Participate in audits to represent general SHL validation approach and related records keeping.
• Drive CAPA related to general SHL validation process and participate in product related CAPA when necessary.
• Ensure all validation records are maintained and periodic verification executed by process owners according to compliance requirements.
• Maintain engineering study platform and ensure all engineering studies that support validation activity are regulated and approved accordingly.
• Develop and maintain performance measurement indices for validation activity and drive continuous improvements to sustain performance.

Required Skills & Qualifications

• Material Review Board
• Change Control approval
• Change Request & review board
• Conduct internal audits
• Support test & sampling development

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.