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Commissioning & Validation Engineer - LSMG

2 months ago

Singapore COGNIZANT TECHNOLOGY SOLUTIONS ASIA PACIFIC PTE. LTD. Full time
About the Role

Cognizant Technology Solutions Asia Pacific Pte. Ltd. is seeking a highly skilled Commissioning & Validation Engineer to join our team. As a key member of our organization, you will be responsible for providing scientific and technical support for lab equipment validation and revalidation activities.

Key Responsibilities
  • Validation and Qualification
    • Develop and execute validation protocols and reports in compliance with cGMPs, SOPs, and regulatory guidelines.
    • Perform lab equipment validations, revalidations, and requalifications, ensuring accurate and timely execution.
    • Author and review summary reports to ensure technical correctness and compliance with internal and external requirements.
  • Equipment Maintenance and Decommissioning
    • Perform lab equipment validation maintenance reviews and re-qualification activities to ensure GMP equipment is continuously maintained in a validated state.
    • Support with decommissioning of lab equipment.
  • Investigations and Project Management
    • Investigate discrepancies during validation and qualification/re-qualification activities.
    • Participate in the coordination of multi-disciplined project teams for validation lifecycle documentations.
    • Ensure approval of validation documentation on a timely basis.
Requirements
  • A minimum of 3 years' experience in pharmaceutical manufacturing and cGMP environment.
  • In-depth knowledge of cGMPs and validation.
  • Familiarity with regulatory requirements and local codes and standards (e.g. FDA, EMEA, GAMP, and ICH Q7).
  • Significant experience within the biotech industry, preferably with lab equipment qualification (LEQ) experience.
  • Experience in a GMP facility, with strong knowledge of GMP regulations.
  • Hands-on working experience with validation and QA.
  • Working experience with validation procedures.
  • Strong communication skills and self-motivation.
  • Team player with a strong focus on safety, quality, and timelines.
About Cognizant

Cognizant (NASDAQ-100: CTSH) is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant is ranked 195 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at https://www.cognizant.com or follow us on social media.