The Principal Advanced Operations Engineer - Technical Lead is a senior technical leader responsible for driving manufacturing excellence, process development, technology transfer, and operational readiness for new product launches. As the primary manufacturing and operations engineering authority within R&D, this role leads cross-functional initiatives to enhance manufacturability, improve operational performance, and accelerate commercialization. The position requires expertise in manufacturing engineering, process validation, lean manufacturing, automation, quality systems, and project leadership.
Key Responsibilities:
Serve as the technical lead for advanced manufacturing and operations engineering initiatives supporting new product development, implementation, and commercialization.
Provide strategic direction for manufacturing process development, optimization, scale-up, operational readiness, and technology transfer to production.
Partner with R&D throughout the product development lifecycle to ensure manufacturability and scalability and drive engineering best practices through Design for Manufacturing (DFM) and Design for Assembly (DFA).
Lead continuous improvement initiatives focused on safety, quality, delivery, and cost performance.
Lead equipment qualification and process validation activities, including IQ/OQ/PQ execution.
Collaborate with Quality, Supply Chain, Manufacturing, Regulatory Affairs, and R&D to deliver successful product launches and process implementations.
Lead multidisciplinary project teams, influence organizational stakeholders, and drive alignment on technical and operational decisions.
Provide technical expertise in lean manufacturing, Six Sigma, advanced manufacturing processes, automation, and process validation methodologies.
Qualifications:
Required:
Bachelor's degree in Engineering or related field.
8+ years of progressive experience in manufacturing engineering, operations, or new product implementation.
5+ years leading complex technical projects and cross-functional teams.
Preferred:
Master's degree.
Experience in regulated industries.
Experience with process validation, equipment qualification, lean manufacturing, and continuous improvement methodologies.
Experience influencing both leaders and individual contributors cross functionally.
United States of America Pay Ranges:
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