Senior Validation Engineer
4 days ago
**Responsibilities**:
- Responsible for planning, executing and closing out the validation activities within the assigned area.
- Develop required validation documents, including Risk Assessments, plans, protocols, and reports.
- Review, analyse, interpret and summarise data of executed studies.
- Investigate or support the investigating of deviations or non-conformities raised during validation studies.
- Provide SME input wherever required.
- Ensure safety, quality and delivery of the validation projects.
- Effectively collaborate with all identified stake holders. Wherever required, collaborate with Global/Corporate functions.
Required Experience & Knowledge
- Minimum Bachelor’s degree in science or engineering discipline
- Minimum 5 years of experience in pharmaceutical CQV.
- In-depth knowledge in the assigned area and of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.
- Fluency in written and spoken English
- Ability to work in a fast paced / dynamic work environment
- A fast learner with “Can-do” attitude
- Good time management skill and great attention to detail.
- Proficient presentation and facilitation skill is a plus.
**EA License No**: 19C9587
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