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CSV Engineer Job Opening In Singapore, Singapore – Now Hiring PSC Biotech Corporation


Job description

Job Description

  • Develop and review validation plans, protocols (IQ, OQ, PQ), and reports for computerized systems.
  • Perform risk assessments and impact analysis related to system validation.
  • Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Collaborate with IT, Quality Assurance, and Manufacturing teams to support system qualification and validation activities.
  • Manage change control and deviation investigations related to validated systems.
  • Support audits and inspections by regulatory authorities.
  • Maintain validation documentation and ensure traceability throughout the system lifecycle.

  • Requirements

  • Bachelor’s degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field.
  • 5-8 years of experience in CSV within pharmaceutical manufacturing or related regulated industries.
  • Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.
  • Experience with validation of PLC SCADA, MES, or other pharma manufacturing Automation systems.
  • Excellent documentation and communication skills.
  • Ability to work independently and in cross-functional teams.

  • Required Skill Profession

    Computer Occupations


    • Job Details

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    The Work Culture

    An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at PSC Biotech Corporation adheres to the cultural norms as outlined by Expertini.

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    1. Independence

    2. Loyalty

    3. Impartiapty

    4. Integrity

    5. Accountabipty

    6. Respect for human rights

    7. Obeying Singapore laws and regulations

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