Validation Senior Engineer

Summary

• Manage validation & qualification activities and system lifecycle from requirements analysis or product development to manufacturing, for equipment / facilities / utilities.

Role & Responsibilities

General:

• Serve as SME for CQV for the Singapore facilities for Drug Product / Drug Substance
• Ensure compliance with appropriate regulatory requirement and WuXi Biologics requirements

C&Q (Singapore Facilities Start-up):

• Develop validation SOPs and C&Q deliverables for project start-up and operation readiness
• Plan, manage and coordinate C&Q activities with internal and external resources/stakeholders
• Review C&Q deliverables from equipment suppliers / C&Q service providers, develop C&Q documents if required
• Attend equipment FAT/training as required
• Track the C&Q deliverables and ensure adherence to schedule from project to operation readiness
• Lead resolution of validation variance / issues in a timely and compliant manner
• Perform lesson learnt to share experiences and implement best practices;
• Provide training and guidance on SOP and skills to team including vendors

CQV (Singapore Facilities Operation):

• Ensure and track qualification status of site through re-qualification program and change control system
• Serve as CQV SME to support the site in audit/visit by clients and regulatory authorities
• Manage and coordinate CQV activities, and develop validation plans if necessary for NPI, Improvement Projects and Shutdown
• Maintain site validation master plan and validation SOPs to maintain consistence of validation strategy with various sites of WuXi Biologics

Education

• Bachelor degree or above, preferably in Engineering Discipline

Experience

• Demonstrated experience in cGMP environment (5 years as a guide)
• Demonstrated experience in start-up facilities is preferred
• Demonstrated experience working in pharmaceuticals facilities in SG, EU or US.
• Demonstrated experience in audits by EMA, FDA and other international authorities is preferred
• Familiar with pharmaceutical production process and equipment validation with minimum of 3 areas (Filling Lines, Lyophilization, Aseptic Process Simulation, Upstream and Downstream Equipment, Cleaning Validation, Sterilization Validation, Computerized System Validation, HVAC/Cleanroom/Clean Air Device, Clean Utilities, Temperature Controlled Units, Shipping Validation, Laboratory Equipment Qualification)

Skills

• In depth knowledge and experience of regulatory requirements and industry standards (21 CFR Part 11/210/211, EU GMP, GAMP 5, ICH Q9/Q10; ISPE Baseline Guides, and PDA TRs.)
• Good understanding of Quality System, EHS.
• Strong collaboration, self-motivation, communication and problem-solving skills
• Demonstrated knowledge of pharmaceutical technology and processes
• Fluent in written and verbal English
• Good at reading and verbal Chinese is preferred.