about the company
Our client is a leading vaccine research company, with their very own R&D facility and manufacturing hub locally in Singapore. This expert in medical research is looking for a reliable and experienced Validation Specialist to join their team during an exciting time in their development.
about the job
- Carry out validation activities associated with the manufacture of biologics and vaccines at the clinical manufacturing facility
- Responsible for validation deliverables such as commissioning, qualifications, PQ and cleaning validations and validation maintenance
- Be the subject matter expert for process equipment qualification on site and act as a adviser to validation challenges on site
- Define facility, equipment qualification and process validation strategy and approach
- Develop validation documents such as concept, plan, report and SOP whenever required
- Deliver re-/qualification /validation milestones according to project and production schedules
- Generate all validation activities in an inspection ready status ahead of any internal and external audits to ensure successful inspections
- Solve various challenges during equipment, cleaning and process qualification/validation by proposing solutions to overcome them timely to meet project and operational schedule
- Schedule validation/periodic monitoring and validation maintenance activities in a timely manner to support production schedule and audit readiness
- Bachelor’s/Master’s Degree in Engineering/Science (Bio/chemical engineering/life science/biology/chemistry) with a minimum of 2-6 years relevant industry experience
- Experience in approving qualification protocols and reports
- Experience in resolving complex qualification/validation related investigations and well versed in various root cause analysis tools
- Experience in technical execution of validation tasks associated with cleaning validation, steaming validation (including autoclaves) and controlled temperature chambers (CTC)
- Knowledge in aseptic filling /process simulation (APS), VHP decontamination/qualification is an advantage.
- Experience in supporting regulatory agency interactions
- Knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
- Experience in clinical manufacturing validation is highly desirable
If you are interested in the position, kindly send your CVs to yiling.tan(@)randstad.com.sg.
Please include your availability, expected salary and reason for leaving your current job.
We regret that only shortlisted candidates will be contacted
Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.
EA: 94C3609 / Reg: R21103172...