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Senior Computer System Validation Engineer
2 months ago
Position: Senior Computer System Validation Engineer
Capricor Inc is in search of a dedicated and detail-focused Senior Computer System Validation Engineer. This role is pivotal in ensuring that computerized systems utilized in the biopharmaceutical sector adhere to regulatory standards. The engineer will engage in the development and execution of validation protocols, meticulous documentation of processes, and offer technical expertise to guarantee systems function efficiently and comply with industry regulations.
Key Responsibilities:
- Oversee Data Process Flow Mapping to ensure compliance of all GMP systems with 21 CFR Part 11 regulations.
- Develop and implement Standard Operating Procedures (SOPs) for Computer System Operation and Administration for all relevant GMP systems.
- Lead and support activities related to Packaging and Label Validation.
- Create and execute validation protocols (IQ, OQ, PQ) for computerized systems to meet regulatory compliance (e.g., FDA, GMP).
- Conduct risk assessments and impact analyses concerning system modifications or updates.
- Collaborate with interdisciplinary 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 assistance and guidance to project teams throughout the system lifecycle.
- Remain updated on industry trends and regulatory changes to ensure ongoing compliance.
- Engage in audits and inspections, addressing findings and implementing necessary corrective actions.
- Support initiatives aimed at continuous improvement of CSV processes and practices.
- Fulfill additional responsibilities related to computer system validation as assigned.
Qualifications:
- Bachelor's degree in Computer Science, Engineering, or a related discipline.
- Minimum of 2 years of proven experience in CSV within a regulated environment (pharmaceuticals, medical devices, etc.).
- Comprehensive understanding of FDA regulations (21 CFR Part 11, Part 210/211) and GMP guidelines.
- Strong grasp of validation principles, methodologies, and best practices.
- Experience with validation tools and documentation systems (e.g., Document Management Systems, LIMS).
- Exceptional analytical and problem-solving abilities, with a strong attention to detail.
- Excellent communication skills, both verbal and written, with the capability to articulate technical information clearly.
- Able to work independently as well as collaboratively within a team setting.
- Relevant certifications (e.g., Certified Validation Professional) are preferred.
