Senior Principal Aseptic Engineer

Job Summary: The Senior Principal Aseptic Engineer leads the strategy, oversight, and resolution of complex process-related issues within aseptic manufacturing operations. This role is accountable for ensuring robust sterility assurance, regulatory compliance, and operational excellence by driving advanced investigations, systemic CAPA effectiveness, and continuous improvement initiatives. The position serves as a subject matter expert (SME) and key liaison during regulatory inspections and high-impact quality events.   Essential Functions of the Job: Lead and oversee complex, high-risk deviation investigations impacting aseptic processing and sterile product quality Establish and standardize investigation methodologies, ensuring consistent application of advanced root cause analysis tools (e.g., 5 Whys, Fishbone, Fault Tree Analysis, FMEA) Provide strategic direction and governance for the CAPA program, ensuring effectiveness, timeliness, and sustainability of actions Act as the aseptic processing SME during regulatory inspections, audits, and client interactions Drive cross-functional alignment between Manufacturing, Quality Assurance, Microbiology, Validation, and Engineering Analyze and trend process, deviation, and environmental monitoring data to identify systemic risks and implement preventive strategies Lead risk assessments related to contamination control, sterility assurance, and process robustness Champion continuous improvement initiatives using Lean, Six Sigma, and operational excellence principles Mentor and develop junior staff and investigation teams, building organizational capability in problem-solving and compliance Support process validation, media fills, and aseptic simulations by ensuring robust issue resolution and risk mitigation Review and approve critical quality documentation, including deviation reports, investigation summaries, and CAPA plans Partner with senior leadership to prioritize and resolve critical quality and operational risks   Supervisory Responsibilities: No direct reports   Minimum Qualifications: Bachelor’s Degree in Microbiology, Biology, Chemistry, Engineering, related field or equivalent experience 15+ years of experience in aseptic/sterile manufacturing Deep expertise in aseptic processing, contamination control strategies, and cleanroom operations Extensive experience leading complex deviation investigations and CAPA programs Strong knowledge of global regulatory requirements (FDA, EMA, ICH, PIC/S) Demonstrated leadership in cross-functional environments   Preferred Qualifications: Advanced Degree Lean Six Sigma certification (Black Belt preferred) Experience leading regulatory inspections and responding to audit findings Familiarity with advanced data analytics tools and digital quality systems (e.g., TrackWise, Veeva) Bilingual in Spanish    Knowledge and Skills: Demonstrates a strong service orientation; responsive and composed under pressure, with a clear sense of urgency, acute attention to detail, and a high level of integrity and professionalism Adapts effectively to changing situations; flexible and resourceful in fast-paced environments Strategic thinking and decision-making Advanced problem-solving and analytical capability Influential leadership and stakeholder management Strong communication and executive presence Risk-based thinking and quality mindset Ability to manage ambiguity and high-pressure situations   Work Environment/Physical Demands: Combination of cleanroom (aseptic gowning required) and office settings Frequent interaction with manufacturing floor operations May require extended hours or on-call support during critical events or investigations   Other Considerations: Up to 50% travel