Process and Equipment Engineer
The Process & Equipment Engineer will support design and installation of new process equipment, commissioning, validation, and ongoing manufacturing operations. Manufacturing support includes modifications to existing equipment for operational efficiency, reliability and new program implementation associated with tech transfers. The incumbent understands industry-wide and Regulatory expectations for validation and works with other teams to ensure equipment validation practices are consistent with requirements and expectations.
• Provides Project Management oversight for equipment related projects
• Leads startup & executes commissioning and validation for new and modified systems
• Coordinates tracking of validation protocol execution status and ensures completion of validation projects per required schedules
• Identifies and executes equipment related changes.
• Represents engineering on Tech Transfer, and cross-functional teams
• Maintains asset management system for all GMP equipment
• Conducts risk assessments and implements corrective actions
• Maintains personal training, goal development / completion, compliance workflow tracking, & progress tracking
Bachelor’s Degree with a minimum of 6 years’ experience biotech or gene therapy manufacturing.
• Practical knowledge and application of GMP and EMA regulations
• Experience with commissioning and validation of GMP process equipment
• Competency in MS Word, MS Excel, MS Power Point and MS Project
• Excellent oral and written communication skills
This is an exciting time to participate in the field of gene therapy in general, and to become a part of Kriya Therapeutics’ fast-growing dedicated team. Kriya Therapeutics offers an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.
All interested applicants should send a cover letter and resume to: [email protected]