Quality Engineer III - Process Validation

Quality Engineer III – Process Validation

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.
• Provide QA support during manufacturing hypercare and critical operations, offering on-floor oversight over processes when needed.
• 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…