Director, Technical Transfer & Process Improvement

• 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 responsibilities: 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.

• 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.

$150,000 - $190,000 annually + bonus

Why you’ll want to join Hygiena:

🚀 Teamwork as a core value

Our emphasis on teamwork and cross-functional communication enables us to build stronger bonds within our business.

🌍 Be a part of something big

We play a critical role in helping to prevent global health crisis such as foodborne illness, healthcare-associated infections, and other outbreaks.

💝 Giving back to our communities

We believe in giving back by supporting local organizations committed to improving the lives of children and youth in our communities.

• 15 days of PTO & 10 paid company holidays
• Medical with HSA employer contribution, Dental, Vision available 1 st 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

We are an equal opportunity employer and value diversity.

All employment is decided on the basis of qualifications, merit and business need.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Hygiena participates in E-Verify.