Principal Compliance Engineer

Main Responsibilities

• Lead and support GMP investigations for clinical manufacturing deviations with scientific rigor, utilizing root cause analysis methodologies and cross-functional collaboration to ensure timely batch release decisions.
• Serve as a process SME for the GCM group providing technical expertise on process related quality events, manufacturing troubleshooting, and urgent production issues.
• Conduct on-site investigations (gemba) with internal and external manufacturing teams to identify process improvements and resolve quality issues.
• Perform product impact assessments for deviations and quality events, applying science-based decision making allowing for batch disposition.
• Manage investigation documentation and closure within internal QMS systems, ensuring regulatory compliance and traceability.
• Collaborate with the internal raw materials team and external suppliers (raw materials, single-use consumables) to investigate quality issues and propose supplier improvements.
• Participate in Risk Management teams Continuous Improvements and Lean Initiatives.
• Partner with Manufacturing, Quality, Process Development, Analytical Development, and other departments to recommend and implement CAPAs based off investigational conclusions.
• Aid in increasing operational efficiency through the implementation of Lean and 5S initiatives across manufacturing areas.
• Regularly assess and enhance lean/5S/SMS knowledge.
• Support efforts to evaluate the efficiency of the existing lean systems, suggesting mitigation strategies for issues identified.
• Participate in efforts to improve ways of working while conducting investigations and documenting quality events.
• Collaborate with the process development team to implement solutions to improve process efficiency and product quality.
• Collaborate with Process Development process trending leads to analyze in-process and final GMP batch data to evaluate process efficiency.
• Participate in Data Insights team to evaluate data trends across the organization GCM Performance Tracking and Evaluation.
• Create and present quality event trending and metrics reports with suggestions for continuous improvements.

About You

• Education: BS in Engineering, Life sciences or related disciplines; OR MS in Engineering.
• Experience: 10+ years of industry experience with at least 5 years of experience in GMP processes or related/equivalent.
• Soft skills: Excellent communication skills, with the ability to provide clear and concise guidance on technical tasks, scheduling challenges, and proposed solutions. Experience with Microsoft office applications. Demonstrated ability to work on multiple projects effectively and maintain exceptional attention to detail. Highly organized, with exceptional attention to detail and strong proficiency in documentation. Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders. Results-driven with a strong focus on achieving operational and organizational objectives.
• Technical skills: Strong GMP investigation experience with experience in driving cross-functional team collaboration through complex manufacturing deviations and quality events. Demonstrated analytical and problem-solving skills with ability to perform science-based risk assessments and impact evaluations as it relates to GMP manufacturing. Expertise in root cause analysis methodologies (e.g., Fishbone, 5-Why, Fault Tree Analysis) and when to appropriately apply methods. Demonstrated knowledge/understanding of manufacturing process or experience in technical/process development, process/technology transfer, and GMP manufacturing, with a focus on mRNA, biologics or ATMPs (expertise in any of these areas is highly valued). Experience with deviation management and implementing corrective and preventative action (CAPA). Strong familiarity with quality management systems and quality event management processes. Understanding of product and process manufacturing data and how to perform analysis to support root cause determination.