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Senior Validation Engineer
3 weeks ago
Title :: Senior Validation Lead
Location : Guangzhou, Guangdong Province, China (Onsite – near Hong Kong)
Position Summary
The Senior Validation Lead will provide strategic and hands-on leadership for validation activities supporting manufacturing systems and R&D laboratory equipment at the Guangzhou site. This role requires close collaboration with Quality, Manufacturing, IT, Engineering, and Regulatory teams to ensure systems and equipment are validated and maintained in compliance with global regulatory requirements. The ideal candidate is fluent in Chinese, experienced in MES and laboratory system validation, and capable of leading validation efforts in a fast-paced, highly dynamic environment.
Key Responsibilities
Lead and manage end-to-end validation activities for Manufacturing Execution Systems (MES), R&D laboratory equipment, and supporting computerized systems.
Develop, review, and approve validation deliverables, including Validation Master Plans (VMPs), risk assessments, IQ/OQ/PQ protocols, reports, and traceability matrices.
Ensure validation activities comply with applicable regulatory requirements and industry standards (e.g., GxP, data integrity, CSV/CSA principles).
Provide validation support for PLT/SCADA systems, including change management, system upgrades, and periodic reviews.
Act as a key validation representative during internal and external audits, inspections, and regulatory assessments; support audit preparation and response activities.
Collaborate cross-functionally with Manufacturing, Quality Assurance, IT, Engineering, and R&D teams to align validation strategies with business and regulatory needs.
Lead validation planning, scheduling, and execution to support project timelines and operational priorities.
Identify validation risks and proactively develop mitigation strategies to ensure system and equipment readiness.
Mentor and guide junior validation team members, providing technical oversight and best-practice guidance.
Drive continuous improvement initiatives related to validation processes, documentation, and compliance.
Required Qualifications
Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related discipline.
Extensive experience in validation of Manufacturing Execution Systems (MES).
Strong hands-on experience validating R&D laboratory equipment and associated computerized systems.
Fluency in Chinese (spoken and written) and ability to communicate effectively with local and global stakeholders.
Proven experience working in regulated manufacturing environments.
Demonstrated ability to manage multiple priorities in a fast-paced, evolving environment.
Preferred Qualifications
Experience with PLT and/or SCADA systems.
Strong audit and inspection support experience, including direct interaction with regulatory authorities.
Project Management Professional (PMP) certification or equivalent project management experience.
Experience leading validation activities for large, complex projects in a global organization.
Key Competencies
Strong leadership and stakeholder management skills
Excellent problem-solving and risk-based decision-making abilities
High attention to detail with a compliance-focused mindset
Ability to work independently while effectively collaborating within cross-functional teams
