Automation Specialist for FDA Regulated Environments
1 month ago
Instrumentation & Control Solutions is seeking an experienced Automation Specialist to join our team. As a key member of our team, you will be responsible for performing Computer System Validation (CSV) on various systems and programs.
About the RoleThis is a consulting position that requires a strong understanding of FDA cGMP regulations and computer validation methodologies. You will work closely with our clients to design, implement, and validate automation solutions that meet their specific needs.
Responsibilities- Perform CSV on a variety of systems and programs using your knowledge of FDA cGMP and related regulations and guidelines.
- Collaborate with cross-functional teams to develop and implement automation solutions.
- Design and execute validation plans, including IQ, OQ, PQ, RTM, and summary reports.
- Maintain accurate and detailed documentation of all validation activities.
To be successful in this role, you will need:
- A minimum of 2 years of experience in computer system validation or related field.
- Strong knowledge of FDA cGMP regulations and computer validation methodologies.
- Excellent communication and project management skills.
- Proficiency in MS Office tools and ability to learn new software quickly.
We offer a competitive salary range of $85,000 - $110,000 per year, depending on experience. Our benefits package includes health insurance, retirement plan, and paid time off. If you are a motivated and detail-oriented professional looking for a new challenge, please apply today
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