Senior Principal Aseptic Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and manage intricate, high-risk deviation investigations that affect aseptic processing and the quality of sterile products.

• Develop and standardize investigation methodologies to ensure the consistent use of advanced root cause analysis tools (such as 5 Whys, Fishbone, Fault Tree Analysis, FMEA).

• Provide strategic direction and oversight for the CAPA program, ensuring the actions taken are effective, timely, and sustainable.

• Serve as the Subject Matter Expert (SME) in aseptic processing during regulatory inspections, audits, and client interactions.

• Foster cross-functional collaboration among Manufacturing, Quality Assurance, Microbiology, Validation, and Engineering teams.

• Analyze and trend data related to processes, deviations, and environmental monitoring to identify systemic risks and implement preventive measures.

• Lead risk assessments concerning contamination control, sterility assurance, and process robustness.

• Advocate for continuous improvement initiatives utilizing Lean, Six Sigma, and operational excellence methodologies.

• Mentor and cultivate junior staff and investigation teams, enhancing the organization's problem-solving and compliance capabilities.

• Support process validation, media fills, and aseptic simulations by ensuring effective issue resolution and risk mitigation.

• Review and approve essential quality documentation, including deviation reports, investigation summaries, and CAPA plans.

• Collaborate with senior leadership to prioritize and address critical quality and operational risks.

⛳️ Requirements

• Bachelor’s Degree in Microbiology, Biology, Chemistry, Engineering, or a related field, or equivalent experience.

• Over 15 years of experience in aseptic/sterile manufacturing.

• In-depth knowledge of aseptic processing, contamination control strategies, and cleanroom operations.

• Significant experience in leading complex deviation investigations and CAPA programs.

• Strong understanding of global regulatory requirements (FDA, EMA, ICH, PIC/S).

• Proven leadership in cross-functional settings.

• Advanced Degree preferred.

• Lean Six Sigma certification (Black Belt preferred).

• Experience in leading regulatory inspections and addressing audit findings.

• Familiarity with advanced data analytics tools and digital quality systems (e.g., TrackWise, Veeva).

• Bilingual in Spanish.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness programs.

• Opportunities for professional development and continuing education.

• Flexible work arrangements to promote work-life balance.

• Engaging company culture with a focus on innovation and collaboration.