Snr Validation Engineer

Position Summary

This role focuses on providing technical guidance, planning, coordinating, and resourcing validation projects on-site. The successful candidate will ensure the qualification and validation of equipment, facilities, utilities, and processes are carried out in accordance with cGMP and ISO 17025 guidelines. The role also involves leading projects with multiple stakeholders and overseeing a small team to deliver project outcomes for the site.

Duties and Responsibilities

1. Manage and lead validation projects across various lifecycle stages, ensuring delivery is completed on time, to specification, and meets quality standards.
2. Lead, guide, and prepare installation and validation test procedures/protocols in accordance with regulatory requirements, corporate standards, internal procedures, and current industry practices.
3. Plan, communicate, coordinate, and execute simple to complex projects within the organisation and across other sites using planning tools such as Gantt charts and project management systems.
4. Write or support the development of SOPs related to equipment and facility validation projects.
5. Participate in validation project meetings, workshops, staff training, and the preparation of related documentation.
6. Lead the evaluation of systems from different vendors for capital budget submissions and recommend suitable systems based on user requirement specifications and project/site needs.
7. Provide project progress reports and communicate updates with relevant stakeholders.
8. Manage direct relationships with key project stakeholders.
9. Initiate and lead projects aimed at improving process efficiency and productivity.
10. Represent the department during client audits as a subject matter expert when required.
11. Independently perform investigations and apply root cause analysis tools such as 6M, Ishikawa fishbone diagrams, or other relevant methodologies, while evaluating practical corrective actions.
12. Communicate investigation findings clearly, accurately, and concisely.
13. Monitor and analyse cost expenditure trends over defined periods to assess departmental cost-effectiveness.
14. Maintain accurate records and documentation in compliance with good documentation practices, ISO/IEC 17025, cGMP, PIC/S, ISPE Guidelines, WHO Technical Reports, organisation SOPs, and data integrity principles.
15. Work closely with all departments to ensure operations are maintained in a validated environment in line with existing QMS and regulatory requirements.
16. Perform all assigned responsibilities with a high degree of accuracy and adherence to quality standards.
17. Review processes within assigned responsibilities, identify areas for improvement, and recommend enhancements to line management.
18. Adhere to organisational policies and procedures.
19. Undertake additional duties or responsibilities reasonably assigned by management within the scope of the role.

General Requirements

• Degree in Engineering, Biomedical Sciences or related fields
• Min 5 years experience in GMP environment

Interested applicants, please email your updated CV to ***email_hidden*** or WA 97527630 for more information.

We regret to inform that only shortlisted candidates will be contacted.

EA Personnel: Lim Ruo Yi, Rachel (R23116144)

Company EA license No.: Recruit Express Pte Ltd (99C4599)