Within the Modulus Manufacturing Facility, the Validation Engineer (Intern) participates in setting up and running the validation lifecycle management program for the facility in Tuas. He / She will be working closely with engineering, manufacturing, safety and quality teams to implement a lean, compliant and efficient validation program.
Key accountabilities
- Create Standard Operating Procedures (SOP) and training materials for Validation Lifecycle Management
- Lead / execute validation activities as part of the site start up activities.
- Create an efficient system / mechanism to generate the annual validation plan / report for GxP system
- Design and implement qualification and validation template / SOP to standardize and support the best way of working for more routine requalification activities
- Develop validation deliverables including risk assessments, system impact assessments, requirement traceability matrix, validation plans, protocols and reports
- Ensure compliance with cGMP as well as all Sanofi Quality requirements.
Skillsets Expected
- Innovation skills in project and production environment / Think out of the box
- Ability to work in multi-disciplinary and multicultural team / Excellent communication ability / Team spirit
- Self-starter, proactive, self-organized and Independent
- Excellent analytical, consultative, and diagnostic skills with ability to make scientific, data driven decision
- Proficient in spoken and written English, with a keen eye for detail
Work Environment
- This role is based at our Modulus facility in Tuas, Singapore, requiring full-time presence on-site.
- The nature of manufacturing operations and the importance of face-to-face collaboration with various stakeholders necessitates working from our facility to ensure optimal team performance and operational excellence.
- Typical work hours for this role are from 7.45am to 4.45pm, Monday to Friday.
Education and experience
- Currently pursuing Bachelor’s Degree in Engineering or Biological Sciences.
- Good knowledge of biopharmaceutical knowledge and basic understanding of GMP
- Prior experience (including internships) in a manufacturing facility will be an advantage.
