Senior Validation Engineer
2 days ago
We are seeking a qualified professional for the role of Validation Specialist. The ideal candidate will have expertise in computer system validation and quality compliance in FDA-regulated industries.
The successful applicant will possess a strong understanding of fundamental cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
They will also have hands-on experience in EDMS & Test Management tools, as well as a proven ability to develop clear, concise, and timely oral and written reports.
Additional requirements include the ability to work on complex projects with general direction and minimal guidance, handle multiple projects and meet deadlines, and manage priorities and workflow effectively.
Responsibilities- Bachelor's degree in a related field or equivalent required.
- 5-8 years of hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
- Familiarity with fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
- Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
- Hands-on experience in EDMS & Test Management tools.
- Understanding of FDA's recent guidance on transition of CSV to CSA.
- Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills.
- Ability to work on complex projects with general direction and minimal guidance.
- Ability to handle multiple projects and meet deadlines.
- Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
Key Skills:
- Excellent written and oral communication skills.
- Ability to work independently with minimal supervision.
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