Summary :

We are seeking an experienced Process Validation Engineer to lead validation strategy, execution, and documentation. The role provides technical leadership across manufacturing, development, quality, and project teams within a cGMP environment.

Roles & Responsibilities :

" Develop and implement process validation, qualification, and CPV strategies. " Generate, review, and approve validation protocols and reports. " Design, schedule, execute, and evaluate qualification and validation studies. " Lead validation investigations, impact assessments, and process control strategy development. " Analyze process and product data to evaluate performance and identify improvements. " Serve as a validation SME during audits and customer meetings. " Manage validation activities across cross-functional manufacturing, development, quality, and project teams. " Provide technical leadership and influence teams without direct authority.

Education & Experience :

" 7+ years of experience in a cGMP environment. " 5+ years of Process Validation, PPQ, and/or CPV experience. " FDA or regulatory-agency BLA filing experience. " Commercial manufacturing experience. " Experience managing validation activities. " Bachelor's or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or a related Life Science field. " Strong technical writing, communication, documentation, and organizational skills. " Strong critical thinking and technical problem-solving abilities. " 10+ years of manufacturing, process validation, PPQ, and CPV experience. " Hands-on experience with cell culture, upstream processing, and/or downstream purification operations. " Experience with cGMP document control systems and procedures. " Strong process and product data analysis experience. " Experience leading and influencing cross-functional teams without direct authority.