Quality Engineer

Role Summary

Lead QA Associate to support biologics manufacturing operations with emphasis on enhancing and maintaining quality oversight and compliance systems for validation activities. This role also involves supporting and coordinating day-to-day activities related to system and software validations, onboarding new equipment, and routine facility, utility and equipment calibration and maintenance programs.

Responsibilities

• Review GMP validation documentation for risk assessment, system classification, URS, IOQ, PQ protocols and reports, and calibration and maintenance documentation
• Collaborate cross-functionally—including Process Development, QC, Manufacturing, and Validation—to support capital projects, scale-up, tech transfer, and inspection readiness
• Represent Quality for validation activities generated on the site or impactful to the site
• Support computer system validation policies and overall strategies and ensure compliance and consistency with regulatory requirements and best industry practices
• Provide quality input on the development of validation policies, procedures, standards and templates
• Review and approve technical documents throughout the equipment/system lifecycle from commissioning, qualification and/or validation through decommissioning, including validation plans, risk assessments, test protocols and reports
• Provide input into validation and testing strategies based on system risk, complexity, and other relevant factors and ensure all validated systems and documentation comply with applicable regulatory requirements
• Support other Quality Operation activities such as on-the-floor presence, material disposition and deviation/capa management

Qualifications

• Bachelor’s degree in life science, biology, biotechnology, or a related scientific discipline
• 5+ years of experience in QA or QC within a biologics or pharmaceutical manufacturing environment
• Previous experience working in a GMP regulated facility with focus on GMP validation activities such as generation, execution and approvals
• Familiarity with different types of validation such as laboratory and manufacturing equipment, facility and utility cleanroom systems, validation documents, and vendor qualification and validation requirements
• In-depth understanding of cGMP, FDA, and EU regulatory requirements
• Excellent communication, documentation, and organizational skills
• Ability to work independently and collaborate effectively with cross-functional teams
• Familiar with Master Control, Blue Mountain and Kneat applications

Education

• Bachelor’s degree in life science, biology, biotechnology, or a related scientific discipline