Validation Engineer
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- RQ of Utilities (WFI)
- Process RQs (SIP, Bulk Sterilization,
Autoclave)
- Cleaning validation
- Warehouse mapping
- Filtration skids
- Mixing tank
- Washer qualification
- Trending of Results
- Data mining
- LIMS queries
- Develop, review and/or approve validation lifecycle
document and protocols/reports in accordance with relevant policies, standards,
procedures and guidelines, and completed in a timely fashion.
- Lead project validation activities, and provide
basic guidance and direction to junior project engineer as required.
- Review Turnover / Vendor Packages as part of the
project deliverables to support qualification activities.
- Manage qualification execution and lead
validation deviation investigation encountered in qualification
- Collaborate with multi functions to arrange, plan
and ensure smooth running of the qualification activities.
- Able to manage cross function stakeholders, and to
lead / facilitate meeting and discussion relevant to project qualification/
validation activities.
- Participate in site Validation Maintenance Program.
- Support Change Implementation on site.
- Any other tasks as and when assigned by Supervisor
or Project Lead.
Requirements
- Preferably 10 years and above of experience for a senior role
- 3-5 years of experience in mid-level role
- 0-3 years of experience in a junior role