Senior Computer System Validation Engineer
2 weeks ago
Position: Senior Computer System Validation Engineer
Capricor Inc is looking for a dedicated and detail-focused Senior Computer System Validation Engineer to enhance our innovative team. The ideal candidate will play a crucial role in ensuring that our computerized systems adhere to industry regulations within the biopharmaceutical sector. This position involves the development and execution of validation protocols, thorough documentation of processes, and providing expert guidance to ensure systems function optimally and align with regulatory standards.
Key Responsibilities:
- Oversee Data Process Flow Mapping to guarantee all GMP systems comply with relevant regulations in preparation for submissions.
- Develop and implement Standard Operating Procedures (SOPs) for the operation and administration of all applicable GMP systems.
- Lead and support validation activities related to packaging and labeling.
- Create and execute validation protocols (IQ, OQ, PQ) for computerized systems to ensure adherence to regulatory standards.
- Conduct risk assessments and impact analyses concerning system modifications or updates.
- Collaborate with cross-functional teams to establish user requirements and specifications for computer systems.
- Draft and review technical documentation, including validation plans, test scripts, and summary reports.
- Perform testing and document outcomes to confirm systems meet functional and performance criteria.
- Provide technical support and guidance to project teams throughout the system lifecycle.
- Stay updated on industry trends and regulatory changes to maintain compliance.
- Engage in audits and inspections, addressing findings and implementing necessary corrective actions.
- Support ongoing improvement initiatives related to Computer System Validation processes and procedures.
- Undertake additional responsibilities related to computer system validation as required.
Qualifications:
- Bachelor's degree in Computer Science, Engineering, or a related discipline.
- A minimum of 2 years of proven experience in Computer System Validation within a regulated environment.
- Comprehensive knowledge of FDA regulations and GMP guidelines.
- Strong grasp of validation principles, methodologies, and best practices.
- Experience with validation tools and documentation systems.
- Exceptional analytical and problem-solving abilities, with a strong attention to detail.
- Effective verbal and written communication skills, capable of conveying technical information clearly.
- Able to work independently as well as collaboratively within a team setting.
- Relevant certifications in validation are preferred.
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