Validation Engineer

Responsibilities

• 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.

Qualifications

#J-18808-Ljbffr