Director, Technical Transfer & Process Improvement

Hygiena provides rapid microbiology diagnostic tests and solutions for mission‑critical, time‑sensitive processes around the world. Hygiena’s proprietary diagnostic technologies enable customers to; prevent illness and save lives, comply with regulations, protect products and brands, run businesses more effectively. Solutions are sold in a wide range of industries globally, but the core focus is food safety.

Headquartered in Camarillo, California and with offices around the world, we are actively looking for talented individuals to help grow the business!

With rapid growth comes opportunity. We are looking for an Director, Technical Transfer & Process Improvement to join our team onsite in our Camarillo, CA office! This is a full‑time / exempt position.

• Serve as the technical SME for establishing and piloting manufacturing processes for new product introductions.
• Partner with Operations to investigate and resolve in‑process deviations, fill‑volume variation, contamination, and product performance issues.
• Lead on‑floor studies and process Kaizens to verify hypotheses and drive sustainable process improvements.

• Lead or support investigations into complex product or process failures using structured problem‑solving.
• Design and execute laboratory experiments to confirm root causes and verify potential solves.
• Work within a matrixed structure with R&D, Quality, and Operations to implement CAPAs that address systemic issues.
• Prepare detailed technical reports summarizing findings, statistical analyses, and recommendations. Generate time‑based quality data trending to help identify areas for improvement.
• Ensure that investigations stay properly structured, appropriately scoped, and promptly executed in a disciplined manner.

• Develop and execute validation protocols (IQ/OQ/PQ) for new equipment, processes, or materials.
• Serve on technical project teams late in development to become proficient with the product in order to robustly support technology transfer from R&D to manufacturing, ensuring design intent and CTQ aspects are maintained. Create, improve, and oversee a systemology and set of best practices for technical transfer.
• Formulate, review, and approve pilot validation reports, ensuring compliance with ISO 13485 and Hygiena’s quality system requirements.
• Participate in process qualification activities for new manufacturing equipment.
• Create, validate, and troubleshoot production processes linked to product manufacturing across our global production organization.
• Drive continuous improvement projects aligned with corporate quality and operational excellence goals across the global organization.
• Apply Lean and Six Sigma methodologies to optimize processes and reduce variation and waste.
• Collaborate across global sites to harmonize best practices, procedures, and work environments.
• Monitor and trend process data to proactively identify opportunities for improvement.
• Responsible for managing and directing a global team of manufacturing scientists, technical transfer specialists, and process improvement engineers
• Lead a highly visible, multi‑functional team in building a robust, structured, and disciplined portfolio progression function
• Lead our global operational excellence culture
• Ensures compliance with and/or follows all organizational systems, programs, training, policies, and procedures as required and complies with relevant legal mandates. Seeks guidance as necessary.
• Actively supports and participates in the safety program, both for self‑protection and the protection of other employees, by reading and abiding by all requirements in the Safety Manual and Injury Illness Prevention Program (IIPP).
• Carries out all responsibilities in an honest, ethical and professional manner.
• Must be able to fulfill essential job function in a consistent state of alertness and safe manner.
• Handles various other duties as delegated by the CSO.

In accordance with applicable policies/procedures and Federal/State laws, may perform the following supervisory…