Senior Validation Engineer
Responsibilities:
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Develop, review and/or approve validation lifecycle documents and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
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Lead project validation activities, and provide basic guidance and direction to junior project engineers as required.
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Review Turnover / Vendor Packages as part of the project deliverables to support qualification activities.
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Manage qualification execution and lead validation deviation investigation encountered in qualification.
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Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities.
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Able to manage cross functional stakeholders, and to lead / facilitate meeting and discussion relevant to project qualification/ validation activities.
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Participate in site Validation Maintenance Program.
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Support Change Implementation on site.
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Any other tasks as and when assigned by Supervisor or Project Lead.
About You:
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Engineering/Science Degree or higher from recognised institution
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At least 5 years of experience in Cleaning validation and Equipment Qualification in the pharmaceutical/biotech industry. Experience in Critical Utilities, and temperature mapping is preferred.
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Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
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Good oral and written communication skills
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Meticulous and Systematic
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Team player, with strong focus on safety, quality and timeline