Validation Lifecycle Management Expert
4 weeks ago
**Job Description:**
We are seeking a highly skilled Computer Systems Compliance Specialist to join our team at Validation & Engineering Group. The ideal candidate will possess a strong understanding of biotechnology industry regulations and compliance principles.
Key Responsibilities:
- Design and execute validation plans for computerized systems in biotech labs and manufacturing environments.
- Perform risk assessments to prioritize system validation based on impact to patient safety, product quality, and regulatory compliance.
- Develop and implement change control processes for validated systems, assessing the impact of changes on validation status.
- Support internal and external audits by providing necessary documentation and demonstrating compliance with validation and regulatory requirements.
Requirements:
- Bachelor's degree in Life Sciences, Computer Science, Engineering, or related fields.
- Minimum of 3-5 years of experience in computer systems validation in the biotechnology or pharmaceutical industry.
- Knowledge of validation for LIMS, MES, and EBR systems in biotech environments.
- Strong analytical thinking and problem-solving skills.
Salary Range: $85,000 - $105,000 per annum, depending on qualifications and experience.
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