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.

Pay: $4,500.00 - $6,000.00 per month

Experience:

• Validation Lifecycle: 1 year (Preferred)
• IQ/OQ/PQ: 1 year (Preferred)
• Pharmaceutical : 1 year (Preferred)
• GMP: 1 year (Preferred)

Work Location: In person