Rotate Device

Job Openings

Senior Computer System Validation Engineer



Job Description

This individual will be a member of Global IT Team. The person will be responsible to understand quality and compliance requirements for ERP application. Ensure IT systems are updated with the latest validation & compliance requirements in all the markets where HSO's products are sold. Ensure that all ERP systems globally follows the QA standard operating procedure for compliance.

Key Responsibilities

  • Involve with the ERP projects to support and translating the business requirements into validation & compliance requirements
  • Plan, organize, execute & document IT&QA activities with IT team for ERP system projects & regulated systems
  • Handle change control requests as per IT and Business Standard operating procedure to ensure that sufficient documentation are in place
  • Strong experience in managing testing throughout the SDLC for MES, establishing Validation Plans (VP) and Testing Strategy
  • Hands-on experience in writing test cases, test data preparation and test execution. Expertise in writing test scenarios using design specification documents
  • Good knowledge in writing testing/qualification protocols
  • Prepare computerized systems documents, VP/VMP, URS, FDS/FRS, SDS/TDS/DDS, XQP, TRM/RTM, RA, IQ, OQ, PQ, XQR, WIs, SOPs, Forms, Traceability Matrix and Validation Summary Reports
  • Coordinate with QA and business operations for validation activities, perform installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) activities
  • Ensure compliance of IT regulations in security, quality and environmental prospective (e.g., ISO 19001, I SO14000, etc.) as well as global IT policies and procedures
  • Support Global CSV Lead on quality and compliance of ERP systems



  • Bachelor’s in computer science or Information Technology or Bachelor of Science with IT background


Experience/ Skills

  • Minimum of 3-5 years of experience in Computer Systems Validation processes.
  • Preferably with experience in software validation from medical device industry or pharmaceutical industry
  • Good understanding of system development life cycle
  • Exposure to FDA compliance CFR part 11 and EMA Annex 11.
  • Experience in Manufacturing systems
  • Good Project Management skills to complete assigned CSV projects individually
  • Good communication skills
  • Ability to express thoughts and complex IT solution clearly and in a simplified manner to be understood by non-IT users.
  • Team player. The ability to work as a team with other IT people across the globe is essential
  • Excellent organization, prioritization & problem-solving skills
  • Good at collaborate with cross functional teams across the globe is essential
  • Good at collaborate with cross functional teams


Travel Requirement

  • As per business needs


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