This role is responsible for supporting validation activities including develop, support and implementation. In this role, the engineer must ensure qualification activities are performed in accordance with the company’s policies and procedures, and regulatory requirements.
Responsibilities:
- Support equipment, facilities, utilities qualifications,
- Develop validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and complete execution in a timely fashion,
- Manage qualification execution and lead qualification deviation investigations encountered during qualification
- Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities
- Participate in site Validation Maintenance Program
- Support Change Implementation on site
- Any other tasks as and when assigned by supervisor / Manager
- Support other technical changes and duties as required
About You:
- Engineering/Science Degree or higher from recognised institution
- At least 2 years of experience in Equipment Qualification in the pharmaceutical/biotech industry. Experience in Critical Utilities, process equipment and facilities qualification is preferred.
- Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
- Good Knowledge of Upstream, Downstream and Support Services equipment within the Pharma Biotech Industry.
- Good oral and written communication skills.
- Meticulous and Systematic
- Team player, with strong focus on safety, quality and timeline
- GMP/cGMP knowledge a plus
- Self-motivated and capable of working in diverse team situations with company clients and maintaining a positive attitude towards project challenges.
