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psc biotech corporation

Boon Lay, Singapore Country / Global

Validation Engineer

Job Description

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

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