Validation Manager / Senior Engineer-Computer System

Summary

Manage Computer System Validation activities and system lifecycle, from design requirement analysis to retirement for drug substance and drug product manufacturing.

Job Responsibilities Role & Responsibilities

General:

Responsible for the qualification and validation of Computer System Validation for the Singapore facilities for Drug Product and Drug Substance

Ensure compliance with appropriate regulatory requirements 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)

Maintain and track qualification status of site through periodic review, re-qualification programs and change control system

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

Qualification

Education

Bachelor degree or above, preferably in Engineering and Computer Science Discipline

Experience

Demonstrated experience in validation or QA related work 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

Demonstrated experience with Computerized System Validation in drug substance and drug products (e.g. PLC, Delta V, SCADA, EMS, OT, Validation Lifecycle Management Systems, Temperature Mapping Systems)

Demonstrated experience in implementation of enterprise business process systems is preferred.

Skills

Good knowledge and experience of regulatory requirements and industry standards.

Good understanding of Quality System, EHS.

Strong collaboration, self-motivation, communication, problem-solving and technical writing skills