Added
6 hours ago
Type
Full time
Salary
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Related skills

validation iq/oq/pq 21 cfr part 11 regulatory compliance cleaning validation
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πŸ“‹ Description

  • Develop, maintain, and enforce the site Validation Master Plan across equipment, process, cleaning
  • Author and maintain validation protocols and validation SOPs, including IQ, OQ, and PQ for new and
  • Execute validation studies and issue protocol final reports on time, with defensible conclusions
  • Qualify the introduction of new or changed products, processes, equipment, computer systems
  • Own cleaning and CIP validation β€” coverage testing, chemical concentration and conductivity limits
  • Manage annual CCP and OPRP verification and annual cleaning verification activities

🎯 Requirements

  • Bachelor's degree in engineering, chemistry, microbiology, food science, or a related field, or
  • 3–5+ years of validation, quality, or process engineering experience in regulated manufacturing
  • Technical knowledge of 21 CFR 117 (FSMA preventive controls) and FSSC 22000 or SQF
  • Experience with 21 CFR 106/107 (infant formula) and 21 CFR 113 (thermally processed low-acid foods)
  • Hands-on protocol writing and execution experience β€” IQ/OQ/PQ, process validation, and cleaning
  • Working knowledge of HACCP, aseptic processing, and low-acid food regulations

🎁 Benefits

  • Competitive stock options
  • 401k with employer match
  • Employee medical, dental, and vision insurance 100% covered by Bobbie, with options to add
  • Flexible Time Off Policy
  • 16 paid company holidays, plus an end of year holiday shut down
  • 16 weeks of paid parental leave with the option to take an additional 8 months unpaid
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