Senior Principal Aseptic Engineer

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🕒 3 days ago

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SunOpta

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🍽️ Food & Beverage

🏭 Manufacturing

🤝 B2B

💰 $196.1M Post-IPO Debt - SunOpta on 2023-12

Food & Beverage • Manufacturing • B2B

SunOpta is a natural and organic food products and ingredient sourcing company that produces plant-based beverages, broths, teas, and better-for-you snacks and ingredients. It provides ingredient sourcing, co-manufacturing, private-label and foodservice solutions for brands, retailers and foodservice providers, and emphasizes sustainability, food safety and supply-chain customization. SunOpta’s product portfolio includes oat, soy, almond, coconut and other plant-based beverages, broths and stocks (conventional and organic), fruit-based snacks (bars, bits, twists, strips), tea concentrates, and plant-based ingredient bases (e. g. , Oatbase, Soybase). It distributes through retail, club, foodservice and e-commerce channels across North America.

📋 Description

• 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

🎯 Requirements

• 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 • 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