QA Validation Engineer (Gen)

About Nd

Incorporated in 2007, we are a patient-centric solution provider for the pharmaceutical industry. We are experts in engineering consultancy, commissioning, qualification and validation services, and regulatory quality/compliance in Asia and Europe.

We offer personalized focused solutions for the pharmaceutical industry in engineering consultancy and regulatory quality and compliance. With a sharp focus on delivering value-adding commissioning, qualification, and validation services, we are leading experts in developing the lean CQV methodology. We extend our offerings to GMP-certified software for environmental monitoring and contamination control, paperless validation, training, and professional recruitment services.

We place keen attention on patient safety, process understanding, regulatory compliance and efficiency in the areas of safety, quality, delivery, and cost.

At No deviation, we strive to deliver our best every day. We apply our core values of empathy, integrity, and transparency to every activity, including engagement with our candidates. We are an equal opportunity employer, value diversity, and promote inclusivity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

We are hiring for a QA Validation Engineer to support one of our clients who is a global leader in the design, engineering, and delivery of facilities for high-tech industries.

What you will be doing:

1. Provide QA support for Computerized Systems Validation (CSV), ensuring adherence to regulations (GxP, 21CFR11, etc.).
2. Perform validation quality reviews of lifecycle documents and protocols, including: Automation CSV qualification, Equipment and Facilities Utilities (EFU) qualification, Cleaning validation, Laboratory equipment qualification & IT systems qualification.
3. Act as the primary point of contact for CSV-related topics, offering guidance on change control impact, validation deliverables, and Data Integrity concerns.
4. Ensure computerized systems meet intended use requirements and support business processes effectively.
5. Collaborate across Business, IT, and QA teams to address quality-related topics.
6. Proactively identify and recommend quality process enhancements based on feedback and benchmarking while ensuring compliance with Quality Management Systems (QMS) and Change Management Procedures.
7. Lead and support the deployment of the Review by Exception Process with Manufacturing Execution Systems (MES).
8. Continuously improve the quality and effectiveness of global methodologies for CSV and MES validation.
9. Oversee adherence to System Development Life Cycle (SDLC) protocols, including URS, CSV Risk Assessments, Quality Plans, IQ/OQ/PQ, Quality System Reviews, and Requirement Traceability Matrices (RTMs).

What you will need:

1. Bachelor's degree in Engineering.
2. 2–5 years of experience in a pharmaceutical/sterile operation/biological production environment, with at least 3 years in QA.
3. Strong automation background in the pharmaceutical/biopharmaceutical industry, transitioning into CSV QA validation.
4. In-depth knowledge of CSV, validation lifecycle, and current Good Manufacturing Practices (cGMP).
5. Familiarity with Health Authority standards (e.g., FDA CFR, EU Annex 1).
6. Experience with SDLC protocols, including 21CFR Part 11 compliance.
7. Team player with strong analytical, organizational, and problem-solving skills.
8. Curious mindset with a proactive approach to improving quality processes.

EA License No : 19C9587