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Engineer Technician

Kedah, MY
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Position: Sterilization Technician

Report To: Senior Sterilization Engineer - Strategic Manufacturing

Function and Primary Responsibilities
  • Sterility Assurance Quality system documentation shall meet the requirements of 21 CFR Part 820, ISO 13485, the European medical device directives, the Japanese Pharmaceutical Affairs Law, and other quality system regulations and standards as appropriate.
  • Liaise with superior to co-ordinate product samples and scheduling with test laboratories.
  • Complete cleanroom installation and qualification activities including protocol and report with the applicable manufacturing sites.
  • Ensure the procedures for cleanroom testing, product testing and final release associated with product transfer are complete.
  • Complete facility service qualification activities such as water systems, compressed air, including protocols and reports.
  • Co-ordinate subcontractors to come on site for required testing, ensuring that they comply with local procedures and practices.
  • Adhere to and ensure the compliance of Teleflex's Code of Ethics, all company policies, rules, procedures, and housekeeping standards.
  • Perform other duties requested by superior.
  • Experience in cleanroom installation and qualification requirements.
  • Experience in water system and compressed air installation and qualification requirements.
  • Effective communicator of issues, of facts and ideas/solutions to senior members of the organization.
  • Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts.
  • Excellent interpersonal skills and ability to participate with cross functional teams in projects and innovation.
  • Ability to communicate and to present reports & ideas.
  • Displays ownership of results and a drive to achieve.
  • Must be fluent in English.
  • Attention to detail and accuracy - essential.
  • Complex problem-solving skills for developing creative solutions and meeting objectives are required.
  • Self-motivated to achieve compliant results.
  • Degree & Diploma and relevant experience in supporting sterilization activities.
  • Working experience in Sterilization & Microbiology understanding, with a passion for excellence.
Sub Specialization : Engineering;Biomedical / Biotechnology

Type of Employment : Permanent

Minimum Experience : Fresher

Work Location : Kedah
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