Product Development Engineer (Validation)

Klang, Selangor, Malaysia
Posted 2 months ago

Job responsibilities:

You will be responsible for process validation, test method validation, stability study and other related matters, including the followings:

  • Manage the validation procedure (including equipment, process & test method) and validation master list
  • Establishing validation documents and carry out validation activities including performance qualification and test method validation
  • Conduct periodic validation review (PVR) in a timely manner and perform revalidation when required
  • Generate stability study documents and execute stability study as requested by customers
  • As an admin to manage test equipment (such as tensile tester, smart scope, etc) and ensure the test equipment are operated according to the requirements
  • Revise raw material/product specification when non-technical changes requested
  • Identify and initiate improvement activities through analysis of data from manufacturing records such as capability study, risk analysis, etc.
  • Leading/supporting non-conformance investigation activities derived from internal/external including risk assessment, root cause analysis, implementing corrective & preventive action, etc.
  • Establish stability documents and execute as per customer requirements
  • Provide support in internal, supplier and external audit process
  • Keep abreast of new technology, have in-depth knowledge of products/raw material in order to provide technical support for new product introduction or improvement projects
  • Ensure that subordinate(s) is complying strictly to the company’s rules and regulation that is stipulated in the Employment letter and the HR Manual
  • Identify the subordinate’s training and development requirement
  • Comply with all approved standard operating procedures, work instruction and guidelines that had been trained on
  • Attend to any other job as assigned by superior and complete the assignment given within the agreed time frame
  • Assist and report all quality related matters to the Superior

Job Requirements:

  • Degree in Science, Chemistry Engineering or equivalent
  • Minimum 3 years’ working experience in a manufacturing environment, ideally from the Medical Industry
  • Preferably candidate with knowledge of ISO13485, GMP and FDA 21 CFR Part 11
  • Preferably candidate with experience in handling validation process for medical devices, managing Smartscope and statistic analysis skills
  • Initiative, proactive, resourceful, able to multi-task and work independently
  • Strong interpersonal, analytical and problem-solving skills
  • Able to work in a team and with minimum supervision
  • Good communication skills in English and Bahasa Malaysia
  • Computer literate – Microsoft Office (Excel, Word & PowerPoint)
  • Familiar with Minitab is an advantage
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