Validation Engineer (CQVCSV)
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Job Location:
Denver, CO - USA
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
Seeking a Biopharmaceutical Validation Engineer to support commissioning qualification and validation (CQV) activities for GMP manufacturing equipment and integrated systems. The role requires a self-driven professional capable of authoring and executing validation documentation independently while ensuring compliance with cGMP standards and regulatory requirements.
Key Responsibilities:
- Author review and execute commissioning and qualification protocols (IQ/OQ/PQ) for single-use and multi-use manufacturing equipment.
- Support synchronization of manufacturing equipment and automated systems to ensure compliant operations.
- Develop and maintain validation documentation in alignment with site SOPs and regulatory standards.
- Apply risk-based validation methodologies to streamline qualification activities while maintaining quality and compliance.
Required Experience:
- 4 years of CQV and CSV experience within Life Sciences / Biopharmaceutical industry
- Hands-on experience authoring and executing IQ/OQ/PQ protocols
- Strong knowledge of biologics manufacturing equipment (TFF Chromatography Bioreactors)
- Experience with cGMP environments and 21 CFR Part 11 compliance
- Experience developing Validation Summary Reports Deviation Reports and Traceability Matrices
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
