Job Description

About No deviation
At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development empowering our team members to grow personally and professionally.
Position Overview
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.
Key Responsibilities

• Provide QA support for Computerized Systems Validation (CSV), ensuring adherence to regulations (GxP, 21CFR11, etc.).
• 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.
• Act as the primary point of contact for CSV-related topics, offering guidance on change control impact, validation deliverables, and Data Integrity concerns.
• Ensure computerized systems meet intended use requirements and support business processes effectively.
• Collaborate across Business, IT, and QA teams to address quality-related topics.
• Proactively identify and recommend quality process enhancements based on feedback and benchmarking while ensuring compliance with Quality Management Systems (QMS) and Change Management Procedures.
• Lead and support the deployment of the Review by Exception Process with Manufacturing Execution Systems (MES).
• Continuously improve the quality and effectiveness of global methodologies for CSV and MES validation.
• 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).

Required Qualifications

• Bachelor's degree in Engineering.
• 2-5 years of experience in a pharmaceutical/sterile operation/biological production environment, with at least 3 years in QA.
• Strong automation background in the pharmaceutical/biopharmaceutical industry, transitioning into CSV QA validation.
• In-depth knowledge of CSV, validation lifecycle, and current Good Manufacturing Practices (cGMP).

Familiarity with Health Authority standards (e.g., FDA CFR, EU Annex 1). * Experience with SDLC protocols, including 21CFR Part 11 compliance.

• Team player with strong analytical, organizational, and problem-solving skills.
• Curious mindset with a proactive approach to improving quality processes.

Why join us?

• Generous Leave Policy including 3 days to care for aging family members, reflecting our commitment to family wellbeing.
• 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 company.
• 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.

How to apply
Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!
Please submit your resume, outlining your qualifications and experience relevant to the role, here.