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.
