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Sterilization Validation Engineer I
2 months ago
About the Role
This position supports Equipment and Sterilization Validation processes, including Autoclave, SIP, tunnel, dry heat, and VHP studies, for commercial and new R&D drug development activities. The role involves generating, reviewing, and approving protocols, deviations, and reports, as well as scheduling activities and providing feedback to internal and external customers.
Key Responsibilities
- Technical Support: Assist with understanding and applying principles of sterilization and sanitization processes within the equipment validation scope.
- Documentation: Prepare and review validation protocols and reports for process equipment, utility systems, and environmental chambers.
- Technical Documents: Support the preparation and review of technical documents, including change controls, deviation investigations, validation protocols, and summary reports.
- Validation Activities: Perform validation activities within an aseptic pharmaceutical environment.
- Regulatory Compliance: Implement applicable regulatory requirements, ensuring compliance with FDA, ISO, EMA, and other regulations.
- Start-Up Activities: Provide technical support for temperature mapping and sterilization program start-up activities.
- Requalification Support: Assist with periodic requalification activities for production equipment and systems.
- Root Cause Investigations: Support root cause investigations related to sterilization and other related activities.
- Data Analysis: Analyze manufacturing data using basic statistical principles to identify trends and potential areas for improvement.
- Project Coordination: Coordinate with cross-functional teams on projects aimed at improving productivity and quality.
- Audit Support: Assist in equipment sterilization programs during internal and external audits, including regulatory inspections.
- Process Assistance: Provide technical assistance for investigations into process/product issues and review design requirements as needed.
- Customer Interaction: Support interactions with customers regarding transfer discussions, timelines, and project deliverables.
- Safety Compliance: Contribute to a safe working environment by adhering to safety rules and participating in safety-related activities.
Requirements
- Education: Bachelor's or master's degree in Pharmaceutical Sciences, Engineering, Microbiology or similar degree.
- Experience: Minimum of three (3) years of relevant experience performing validation activities within an aseptic pharmaceutical environment.
- Skills: Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH.
- Software Proficiency: Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
About Renaissance Services
Renaissance Services is a leading pharmaceutical company dedicated to delivering high-quality products and services. Our team of experts is committed to excellence and innovation in the field of pharmaceutical development and manufacturing.
