The Senior Validation Engineer is responsible for the qualification or requalification of laboratory equipment within the targeted schedule.
Responsibilities:
- Responsible for managing and writing of qualification related documentation but not limited to Qualification Plan and IQ, OQ, PQ and ERES Test Scripts for QC laboratory equipment (lab bench and CSV system)
- Responsible for managing and executing requalification of existing laboratory equipment.
- Responsible for the execution of but not limited to IQ, OQ, PQ and ERES Test Scripts of QC laboratory equipment (lab bench and CSV system) and test script for new equipment deployments.
- Manage and maintain the progress tracking matrix on document generation, qualification execution, document review and approval. Escalate the issue/delay to the management team.
- Coordinate and manage deviation to be initiated, assessed and closed out in a timely manner.
- Responsible for stakeholder management including coordination with QC lab team on equipment availability for qualification activity.
- Responsible for all other activities related to qualification activities but not limited to change control, tag out, PM/Calibration program, equipment configuration, SOP generation.
- Work with the IT team to develop the CSPECs, ERES etc to fulfil Part 11 requirements.
- Responsible for managing computerized system validation lifecycle data integrity portion and risk assessment.
- Handover and coordination post LEQ execution to QC lab
- Any other task as assigned by Supervisor/Manager
About You:
- Bachelor in Engineering, Sciences, Business, Information Systems or equivalent.
- Min 5 years of experience in QC Lab Equipment Qualification in pharma or biotech facilities.
- Knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility
- Good interpersonal, communication and presentation skills.
- Must be a self-starter, fast learner, curious with strong analytical and organizational skills
- Self-motivated and willingness to learn
- Reliable and Responsible
