Job Description

Responsibilities:

• Support equipment qualification, system qualification, and cleaning validation.
• 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

• Engineering/Science Degree or higher from recognised institution
• At least 5 years of experience in Equipment Qualification in thepharmaceutical/biotech industry. Experience in Critical Utilities, Cleaning validation and temperature mapping is preferred.
• Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
• Good oral and written communication skills
• Meticulous and Systematic
• Team player, with strong focus on safety, quality and timeline