DuPont Food Safety Engineer/Regulatory Specialist in Palo Alto, California
Food Safety Engineer/Regulatory Specialist (Job Number: 193793W-01)
We are seeking a Food Safety Engineer/Regulatory Specialist to design, implement and manage a FSMA compliant food safety management program for Pilot-scale R&D operations at our Palo Alto, California site. Responsibilities include; i) put food safety prerequisite programs in place across pilot scale operations, ii) design and implement FSMA compliant control programs, iii) generate and manage all regulatory documents, SOPs, food safety plans and other materials related to implementing and maintaining FSMA compliance, and iv) Work with R&D staff to determine and meet food safety program needs for technical projects. The successful candidate must be motivated, creative, have strong problem solving and critical thinking skills, and be capable of working both independently and collaboratively.
Specific Roles and Responsibilities
Put food safety prerequisite programs in place with the goal of attaining food grade compliance for large scale pilot operations (Fermentation, Recovery and Formulations).
Identify and design control programs as required to implement a food safety program consistent with the requirements of FSMA Prepare and review Food safety and HACCP plans for R&D production of enzymes and other bio-products.
Draft regulatory documents, technical reports and other materials to support customer needs.
Collaborate with R&D staff, management and other stakeholders to meet project goals/deadlines.
Work with internal and external auditors to demonstrate food safety program compliance.
Bachelor of Science (BSc) degree in Biology, Chemistry, Engineering or related fields with >5 years experience.
Five years or greater experience in food safety management/quality assurance
Experience in FSMA, cGMP, ISO, HACCP, FSSC 22000 or related quality program implementation and management
Working knowledge of applicable FDA cGMP regulations relevant to food safety (e.g. CFR 21 part 117)
Technical understanding in bioprocess engineering, fermentation, microbiology or related disciplines etc. is preferred.
Knowledge of regulatory requirements governing commercialization of enzymes or other biologically derived products.
Good record keeping skills and excellent attention to detail. Excellent written and verbal communication skills.
Proven ability to work with multidisciplinary teams across multiple projects.
Primary Location: NA-United States-California-Palo Alto
Organization: Industrial Biosciences
Education Level: Bachelor's Degree (±16 years)
Employee Status: Regular
Job Type: Experienced
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