Validation Engineer

Sequoia is seeking a Sr. Validation Engineer to assist with the development and execution of validation protocols for various types processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing and maintaining the validation program.

Responsibilities

• Perform equipment qualifications including Commissioning, IQ, OQ and PQ
• Travel both locally and internationally to help serve various clients
• Write, review, approve, and execute validation protocols
• Create reports summarizing results and statistics
• Develop and communicate expectations for quality performance, continuous improvement, and quality systems
• Assist developers and domain experts in designing, performing, and improving verification tests
• Ensure validation program meets GMP, FDA, and ISO regulations
• Work with scientists, technicians, engineers, and project management to deliver validated equipment and facilities
• Interact with cross-disciplinary teams in order to meet project milestones and end goals
• Collaborate with key stakeholders and client teams to help define needs and achievable solutions and/or justifications for equipment requirements and related validation

Qualifications

• Bachelor’s degree in a related life science field
• Willingness to travel up to 75-100% for projects at client sites
• 4-7 years of experience within the biotech, pharmaceutical or medical device industry
• Knowledge and experience working with FDA cGMP, FMEA and Risk Analysis required
• Validation expertise in Equipment, CSV, Method, and Process
• Protocol generation experience of automated production systems, with a concentration of computerized equipment and systems validation
• Report writing experience IQ, OQ, PQ, and CSV
• Strong verbal and written communication skills and ability to discuss technical topics with non-technical people is strongly desired