Junior Validation Engineer

Responsibilities: • Develop and execute validation (IQ/OQ/PQ) / study protocols as performer or witnessed by (depending on assignment) against approved URS and risk assessments.  • Complete the executed test package with summary report. • Lead or support risk assessments and impact assessments where applicable. • Initiate change control process for any modifications affecting validated state. • Plan, manage and coordinate activities with other functions including equipment suppliers, Engineering, Manufacturing, QC, QA, and Automation/IT. • Track the CQV deliverables and ensure adherence to schedule from project to operation readiness. • Ensure traceability across lifecycle documents • Lead or support resolution of variation / deviation investigation in a timely and compliant manner. • Support administrative, periodic review and document revision related work. About You: • At least bachelor’s degree or above, preferably in Engineering or Science discipline. • Candidate should have at least one year of hands-on CQV experience in the equipment qualification for example autoclave.  • Working experience in supporting smoke study and / or aseptic process simulation is preferable.  • Strong analytical and problem-solving skills.  • Strong time management, communication and collaboration skills.  • Candidate with experience in regulatory inspection by FDA / EMA will have added advantage.  • Strong understanding in Data Integrity requirement (ALCOA+ principles) and Good Documentation Practice.  Duration: 6 months