Senior Principal Aseptic Engineer

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SunOpta

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🍽️ Alimentos e Bebidas

🏭 Manufatura

🤝 B2B

💰 $196.147.079 Post-IPO Debt - SunOpta em 2023-12

Food & Beverage • Manufacturing • B2B

A SunOpta é uma empresa de produtos alimentícios naturais e orgânicos e fornecimento de ingredientes que produz bebidas à base de plantas, caldos, chás e snacks e ingredientes mais saudáveis. Ela oferece fornecimento de ingredientes, co-manufatura, soluções de marca própria e foodservice para marcas, varejistas e provedores de foodservice, com ênfase em sustentabilidade, segurança alimentar e customização da cadeia de suprimentos. O portfólio de produtos da SunOpta inclui bebidas à base de plantas como aveia, soja, amêndoa, coco e outras, caldos e fundos (convencionais e orgânicos), snacks à base de frutas (barras, pedaços, torções, tiras), concentrados de chá e bases de ingredientes à base de plantas (por exemplo, Oatbase, Soybase). A distribuição é feita através de canais de varejo, clube, foodservice e e-commerce em toda a América do Norte.

Descrição

• 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

🎯 Requisitos

• 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