Bioprocessing Validation Specialist
3 weeks ago
We are seeking a highly skilled Bioprocessing Validation Specialist to join our team at Trinity Consultants - Advent Engineering. As a key member of our engineering and consulting firm, you will be responsible for ensuring the quality and compliance of our clients' biotechnology and pharmaceutical manufacturing processes.
Key Responsibilities- Qualification and Validation: Develop and implement qualification and validation plans for bioprocessing equipment and support equipment to ensure compliance with regulatory requirements.
- Documentation and Compliance: Create and review validation and equipment documentation, including risk assessments, URS, FAT/SAT, IOQ, SOPs, and other relevant documents, to ensure compliance with client and regulatory policies.
- High-Level Documentation: Develop and review high-level documentation, such as VMPs, risk assessments, System Level Impact Assessments, criticality assessments, quality plans, commissioning plans, and other relevant documents.
- Regulatory Knowledge: Maintain knowledge of current good manufacturing practices (cGMPs) and good documentation practices (GDP).
- Team Collaboration: Contribute to high-performance/cross-functional teams created to support process improvement, scale-up, technology transfer, engineering, and validation activities.
- Technical Expertise: Function as a technical expert on process equipment or systems and support troubleshooting for complex issues in manufacturing.
- Education: Bachelor's or master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or equivalent educational background.
- Experience: 3+ years of experience in a biotech-pharmaceutical environment.
- Knowledge and Skills: Knowledge of upstream/downstream drug substance manufacturing, commissioning, qualification, and validation (CQV), lifecycle management, regulatory compliance (cGMP, FDA regulations), GAMP 5 methodology, quality systems (deviation, change control, CAPAs), data integrity, and 21 CFR Part 11.
- Communication and Interpersonal Skills: Strong interpersonal, written, and oral communication skills, with proficiency in Excel, PowerPoint, Visio, Word, Sharepoint, and other relevant software.
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