Computer Systems Validation Specialist
4 weeks ago
Sequoia Biotech Consulting is seeking a highly skilled Computer System Validation (CSV) Engineer to ensure the integrity and reliability of computer systems and software used by our clients. The ideal candidate will have a strong background in regulatory requirements and industry standards, with experience in validation of various types of systems, including ERP, LIMS, and MES.
Key Responsibilities
- Develop and implement validation strategies for computer systems and software applications.
- Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports.
- Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems.
- Conduct validation testing and review test results to ensure systems meet specified requirements.
- Provide training and support to staff on validation processes and procedures.
- Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance.
- Participate in audits and inspections by regulatory agencies.
- Bachelor's degree in Computer Science, Engineering, or a related field.
- Minimum of 4-7 years of experience in computer system validation or a related field.
- Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5).
- Experience with validation of various types of systems, including ERP, LIMS, and MES.
- Excellent documentation and technical writing skills.
- Strong analytical and problem-solving abilities.
- Ability to work independently and as part of a team.
- Excellent communication and interpersonal skills.
- Excellent healthcare options: Medical, vision, prescription & dental.
- Family Focus & Balance: Parental leave, flexible time-off, and Employee Assistance Program.
- Financial Security: 401(k) with employer matching.
- Tuition Reimbursement: Continuing education for every season of your career.
- Employee Recognition Programs.
Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $88,423.04 yearly in our lowest geographic market up to $125,935.84 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
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