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Biologics Quality Assurance Engineer
3 weeks ago
Vivex Biologics Inc. is a leading biologics company seeking a talented individual to fill the position of Validation Process Lead. As a key member of our quality assurance department, you will be responsible for ensuring the reliability, consistency, and compliance of our processes, equipment, and systems.
Key Responsibilities:
- Develop and execute validation plans for new and existing processes, equipment, and systems.
- Generate and execute qualification protocols to perform equipment qualifications and process validations.
- Support the company's Master Validation Plan (MVP), including commissioning activities and protocol executions, and establishing re-validation criteria.
Requirements:
- Bachelor's degree in engineering or a related technical discipline (e.g., biology, chemistry, etc.). Proficiency in microbiology preferred.
- At least 4-5 years of experience in a related engineering or quality role, with experience in validations preferred.
- Strong knowledge of FDA, AATB, and cGTP guidelines preferred.
Compensation:
- Competitive salary: $120,000 - $150,000 per year, based on experience.
- Comprehensive benefits package, including health insurance, retirement plan, and paid time off.
