Technical Validation Specialist
1 day ago
Job Overview:
We are seeking a skilled Technical Validation Specialist to join our team at NNIT. This role will involve providing Computerized System Validation (CSV) consulting services to pharmaceutical and medical device manufacturing clients.
Estimated Salary: $90,000 - $120,000 per year
About the Role:
In this position, you will be responsible for managing the system design life cycle (SDLC), including risk, deviation, and change management. You will also ensure good documentation practices, develop and execute test scripts, and review system functions and processes to deliver validation deliverables.
Key Responsibilities:
- Manage SDLC, including risk, deviation, and change management
- Ensure good documentation practices
- Develop and execute test scripts
- Review system functions and processes to deliver validation deliverables
- Develop approaches using science- or risk-based methods that meet regulatory expectations
Requirements:
To be successful in this role, you will need:
- A Bachelor's degree in a technical discipline, such as engineering, science, or IT
- At least 2 years of experience performing CSV activities
- Experience in engineering or process automation, such as DCS, Historian, MES, and/or PLC
- Strong communication skills, both written and verbal
- Able to work independently and as part of a team
- Good organizational skills and attention to detail
- Familiarity with ICH Q7/Q9, 21 CFR Part 11, EU Annex 11, and regulatory requirements
Benefits:
- Consulting roles for pharmaceutical and medical device clients in strategically relevant projects
- Work in a professional consultancy environment within a highly motivated team
- Opportunity to develop skills and deliver projects in both technical and qualification/validation scope
- Opportunity to take on responsibility and help shape our organization
- Excellent career development and growth opportunities in a premier consulting organization
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