Quality Engineer III - Process Validation

About the role

The Quality Engineer III – Process Validation plays a critical role in ensuring product quality and compliance across the entire lifecycle, from New Product Introduction (NPI) through Process Performance Qualification (PPQ) and into commercial manufacturing. This high-level individual contributor position provides phase-appropriate quality assurance oversight, supports technology transfer and process validation, and ensures programs are inspection-ready and aligned with commercialization quality strategies. The role is highly cross-functional and directly supports successful product launches and sustained commercial operations in a fast-paced biologic drug substance manufacturing environment.

Responsibilities

• Serve as the Quality representative and lead on cross-functional program teams to enable successful commercialization readiness from late-stage development through launch and post-launch support.
• Provide phase-appropriate QA oversight for technology transfer, process validation and PPQ readiness, control strategy implementation, and manufacturing scale-up activities.
• Partner with product and program leadership to ensure quality deliverables, timelines, and risk mitigations are integrated into program plans, including risk assessments, readiness reviews, and documentation strategies.
• Ensure alignment with applicable regulations and guidance such as FDA, EMA, and ICH, as well as site quality standards.
• Review and approve GMP documentation including batch records, standard operating procedures (SOPs), technical reports, and quality records such as work notifications.
• Support material disposition and product release activities in accordance with GMP and quality standards.
• Conduct compliance walkthroughs on the manufacturing floor to ensure adherence to GMP requirements and quality procedures.
• Support and lead investigations for deviations, corrective and preventive actions (CAPAs), and change controls, including root cause analysis and documentation of outcomes.
• Apply risk-based decision-making principles to drive compliant, effective, and pragmatic quality outcomes.
• Identify, assess, and mitigate quality risks across operations, proactively addressing potential issues before they impact product or patient safety.
• Contribute to continuous improvement initiatives focused on enhancing quality systems, inspection readiness, and operational efficiency.
• Utilize tools such as Smartsheet and other documentation systems to manage and track quality activities, batch record reviews, and project deliverables.
• Communicate clearly with internal and external stakeholders to document, explain, and justify quality decisions and risk assessments.
• Influence cross-functional teams, manage competing priorities, and make sound quality decisions under timeline pressure.
• Collaborate with manufacturing, technical, and other departments to identify and implement solutions to address quality and compliance issues.
• Provide independent quality oversight with minimal guidance, demonstrating leadership in decision-making and change implementation.
• Support inspection readiness activities and respond to regulatory technical reviews related to FDA and GMP expectations.
• When required, aseptically gown and work in environmental clean rooms to provide on-site quality oversight of validation and manufacturing processes.

Essential Skills

• Bachelor’s degree in a scientific discipline or equivalent experience.
• Typically 5+ years of experience in a regulated GMP manufacturing environment such as biopharma, pharma, medical devices, or similar, including direct Quality oversight.
• Experience supporting New Product Introduction (NPI), Process Performance Qualification (PPQ or PPI), and/or commercial manufacturing activities.
• Strong knowledge of quality systems and their application in a regulated manufacturing environment.
• Demonstrated process validation experience, including regulatory technical review aligned with FDA and GMP requirements.
• Strong working knowledge of current Good Manufacturing Practices (cGMP), data integrity expectations, and inspection readiness principles.
• Hands-on GMP pharmaceutical quality assurance experience, including on-floor QA oversight over manufacturing processes.
• Experience with CAPAs, including investigation, root cause analysis, and implementation of corrective and preventive actions.
• Proficiency in reviewing and working with SOPs and batch records, including batch record review for release.
• Able to apply risk-based decision-making to complex quality and operational scenarios.
• Effective written and verbal communication skills, with the ability to document and explain quality decisions to internal and external stakeholders.
• Strong attention to detail and accuracy in documentation and review.
• Able to perform job functions with minimal guidance and manage multiple priorities in a fast-paced environment.
• Prominent ability to make key and timely decisions and provide independent quality judgment.
• Able to influence cross-functional teams and lead significant change related to quality and compliance.
• Excellent organizational skills and problem-solving abilities.

Additional Skills & Qualifications

• Technical knowledge of biopharmaceutical manufacturing processes is highly desirable.
• Experience with Smartsheet or similar tools for tracking quality activities and documentation is beneficial.
• Experience in inspection readiness and participation in regulatory inspections or audits is an advantage.
• Leadership experience, including influencing others and leading cross-functional initiatives, is a plus.
• Able to work collaboratively with various departments and external partners to identify and implement solutions to quality and compliance issues.
• Able to aseptically gown and work in environmental clean rooms as needed to support on-floor quality oversight.
• Strong capability to manage competing priorities while maintaining high quality standards and meeting timelines.
• Demonstrated commitment to continuous improvement in quality systems and manufacturing processes.