Validation Engineer

• RQ of Utilities (WFI)

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  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