Pharmaceutical Validation Engineer

4 days ago

Singapore beBeeQuality Full time $90,000 - $120,000
Job Overview

We are seeking a skilled Validation Specialist to support key validation activities within our Quality Control (QC) Laboratory. This role involves both software upgrade validation and the decommissioning of legacy computerized systems in a Good Manufacturing Practice (GMP)-regulated environment.


Key Responsibilities:
  • Plan and execute validation activities associated with the software upgrade of laboratory analytical systems.
  • Develop and review validation documentation, including User Requirements Specifications (URS), risk assessments, protocols (Installation Qualification/Orientation/Performance Qualification), and summary reports in alignment with current regulatory requirements.
  • Collaborate with QC and Information Technology (IT) teams to ensure accurate integration of system requirements and compliance with data integrity expectations.
  • Lead or support the decommissioning of computerized systems used within the QC lab, ensuring proper archival of data and documentation during decommissioning, including backup, verification, and system retirement in accordance with company procedures.

Requirements

To be successful in this role, you will require:

  • A Bachelor's Degree in Life Sciences, Engineering, Computer Science, or a related discipline.
  • Proven experience in validation of computerized systems in a GMP laboratory or manufacturing environment.
  • Strong understanding of GAMP 5, FDA 21 CFR Part 11, and Annex 11 requirements.
  • Experience in system decommissioning and data migration strategies.
  • Excellent documentation, organizational, and communication skills.
  • Ability to work independently and collaboratively with cross-functional teams.

Benefits
  • Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
  • Professional Development Opportunities: Access continuous learning programs and resources for career growth within the organization.
  • Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
  • Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

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