Director, Technical Transfer & Process Improvement

Hygiena LLC • Camarillo, CA

15h • $150,000 - $190,000 • Onsite

About The Position

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!

At Hygiena we believe:
In providing the highest quality products & service
Being a leader in innovation
Having a compelling desire to improve and win in the marketplace
In contributing positively not only in the workplace, but in our community and environment!

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.

Requirements

• Bachelor’s Degree in Biology, Microbiology, Biochemistry, Chemistry, Engineering, or a related field, or equivalent education and work experience in a laboratory and manufacturing environment required.
• Minimum of ten (10) years of experience of increasing responsibility working in a laboratory or manufacturing environment required that includes the following: cGMP, aseptic technique, and quality investigations.
• Minimum of three (3) years of supervisory experience managing direct reports required.
• Expert knowledge of technical transfer; including process piloting, gated product development systems, process validation, and documentation
• Strong understanding of ISO 9001/13485 systems, process validation, SOP authoring, and CAPA
• Hands-on proficiency in both laboratory and manufacturing settings, including mastery of aseptic techniques
• Demonstrated success in launching regulated products in the diagnostics industry.
• Demonstrated success in leading investigations and implementing data-driven improvements using statistical and analytical tools
• Six Sigma Green or Black Belt Certification – required
• Hands-on experience working in or closely with R&D
• Intermediate knowledge of Microsoft Office (Outlook, Word, Excel, Visio, PowerPoint) and Adobe Acrobat required.

Responsibilities

• 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.
• Interviewing, hiring, orienting and training employees; planning, assigning, and directing work; coaching and appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; enforcing all safety rules and ensuring safe work procedures.

Benefits

• 15 days of PTO & 10 paid company holidays
• Medical with HSA employer contribution, Dental, Vision available 1st of the month after start date
• Company paid Life Insurance, Short and Long-Term Disability and an Employee Assistance Program
• 401(k) with Safe Harbor and Profit-Sharing employer contributions
• Tuition Reimbursement program
• Charitable Contribution matching
• Employee Referral bonus opportunities
• State paid short-term disability for California based employees

What This Job Offers

• Job Type: Full-time
• Career Level: Director