Purpose: Support equipment qualification, system qualification, and cleaning validation.
Responsibilities:
- 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.
About you:
- Engineering/Science Degree or higher from recognised institution
- 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.
- 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
Note: 6 Months contract (Option to Extend)
