Validation Manager / Senior Engineer-Aseptic Process Simulation

Summary

Subject Matter Expert in Aseptic Process Simulation / Media Fill / Sterile Hold validation and system lifecycle, from design requirements analysis to retirement for drug substance and drug product manufacturing.

Job Responsibilities Role & Responsibilities

General:

1. Responsible for the validation of Aseptic Process Simulation / Media Fill / Sterile Hold processes and smoke studies for the Singapore facilities for Drug Product and Drug Substance
2. Ensure compliance with appropriate regulatory requirements and WuXi Biologics requirements

C&Q (Singapore Facilities Start-up)

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

CQV (Singapore Facilities Operation)

1. Maintain and track qualification status of site through periodic review, re-qualification programs and change control system
2. Support the site in audit/visit by clients and regulatory authorities
3. Manage and coordinate CQV activities, and develop validation plans if necessary for NPI, Improvement Projects and Shutdown
4. Maintain site validation master plan and validation SOPs to maintain consistence of validation strategy with various sites of WuXi Biologics

Qualification

Education

1. Bachelor degree or above, preferably in Engineering and Science Discipline

Experience

1. Demonstrated experience in validation or QA related work experience in cGMP environment (5 years as a guide)
2. Demonstrated experience in start-up facilities is preferred.
3. Demonstrated experience working in pharmaceuticals facilities in SG, EU or US.
4. Demonstrated experience in audits by EMA, FDA and other international authorities is preferred
5. Demonstrated experience with pharmaceutical Aseptic Process Simulation, Media Fill, Sterile Hold validation and smoke studies in drug substance and drug products (e.g. Filling Line, SIP of stainless steel vessels, skids, and transfer lines, autoclave, lyophilization, isolator)

Skills

1. Good knowledge and experience of regulatory requirements and industry standards
2. Good understanding of Quality System, EHS.
3. Strong collaboration, self-motivation, communication, problem-solving and technical writing skills