Validation Engineer

3 days ago

Shanghai, Shanghai, China Medline Industries, LP Full time CN¥60,000 - CN¥120,000 per year

JOB SUMMARY:

Prepare and execute sterilization related activities for medical device and pharmaceutical products. Support various Medline product divisions while assuring appropriate sterility assurance level to comply with FDA regulations and ISO standards. Provide technical consultant, support and troubleshoot sterilization processes and challenges across multiple modalities.

CORE JOB RESPONSIBILITIES:

  • Perform validation or revalidation independently to support management of sterile products in Asia, take on validation of new cycle, supplier owned validation and challenging projects under supervision. Manage conflicts, interact with suppliers and stakeholders, and communicate with internal team and cross-functional teams to push project development.

  • Assign sterilization cycles to new products based on review of materials, product construction, and packaging. Review the validated process to confirm item sterilization.

  • Review the sterilization documentations from sterilization facility against the latest sterilization agreement between Medline and the facility and release the products for sterility purposes if all acceptance criteria for sterility release have been achieved. Issue, track and close CAPA, sterilization investigation, deviation or non-conformance reports when OOS happens.

  • Be able to perform new supplier evaluation and disposition independently. Establish and maintain quality and sterilization processing agreement with sterilization facility.

  • Perform vigilance audit and track corrective actions. Supervise and train supplier for performance of technical studies and routine control, make sure in compliance based on company procedure. Issue, track and close SCAR to supplier under supervision for major quality issues related to sterilization.

  • Perform sterilization related supplier audit under supervision, track CAPA provided by supplier. - Sterilization related database review and update.

  • Other work assigned by line manager.

BASIC Technical Skills:

  • Well known of sterilization and/or packaging related regulations and standards. - Detail oriented with strong written and verbal communication, problem solving and follow up skills.

  • Professional attitude with a heightened sense of urgency to complete tasks accurately and efficiently.

  • Good multiple project management skills, have risk control consciousness

  • Willing to travel with rate 30% to 60%.

  • Proficiency of PC skills: MS Office Software, Statistical Software

Qualification:

Education level: Bachelor's degree or above with science or engineering background. Microbiology background is a plus.

Work experience: 2-5 years' work experience in sterilization/packaging validation, or above 3-5 years' work experience in manufacturing of medical device.

Specific knowledge: Biological and chemical background is preferred.

Certifications: ISO13485, ISO11135, ISO11137, ISO11607, ISO17665, or ISO17025 is preferred. Language: Fluent at both verbal and written English.

Core Competency (MSF):

Focus on the customer

Deliver results

Sense of urgency

Sound judgement

Strong work ethic

Build effective relationships

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