Validation Engineer

Bobbie • Heath, OH

6d • $95,000 - $110,000 • Onsite

About The Position

Bobbie is a parent-founded company that manufactures organic infant formula end-to-end in the U.S. The company is committed to providing parents with confidence, without judgment and without compromise. Bobbie has also been involved in advocacy through its arm, Bobbie for Change, fighting for paid federal parental leave, preventing future formula shortages, and advocating for feeding equity. The Validation Engineer role is crucial for ensuring the safety and quality of infant formula, which is the most regulated food in America. This position will own the validation program at the Heath, Ohio facility, ensuring compliance with FDA regulations and other quality standards.

Requirements

• Bachelor's degree in engineering, chemistry, microbiology, food science, or a related field, or equivalent work experience.
• 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.
• Hands-on protocol writing and execution experience — IQ/OQ/PQ, process validation, and cleaning validation.
• Working knowledge of HACCP, aseptic processing, and low-acid food regulations.
• Familiarity with environmental monitoring program design, including Cronobacter sakazakii and Salmonella zoning, sampling plans, and corrective action.
• Comfort with statistical tools — process capability, sampling plans, and SPC.
• Computer system validation experience and working knowledge of 21 CFR Part 11 and data integrity expectations.
• Experience with an eQMS or LIMS (TrackWise, Optiva, GLIMS, or equivalent).
• Excellent technical writing — protocols, reports, and SOPs that withstand FDA inspection.

Nice To Haves

• Experience with 21 CFR 106/107 (infant formula) and 21 CFR 113 (thermally processed low-acid foods) strongly preferred.
• PCQI, HACCP certification, Better Process Control School, ASQ CQE or CQA, or SQF Practitioner certification are all a plus.

Responsibilities

• Develop, maintain, and enforce the site Validation Master Plan across equipment, process, cleaning, utilities, and computer systems.
• Author and maintain validation protocols and validation SOPs, including IQ, OQ, and PQ for new and modified equipment.
• 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, spreadsheets, and cleaning procedures.
• Own cleaning and CIP validation — coverage testing, chemical concentration and conductivity limits, swab and rinse sampling, allergen and protein residue acceptance criteria, and hold-time studies.
• Manage annual CCP and OPRP verification and annual cleaning verification activities.
• Oversee computer system validation and 21 CFR Part 11 controls: audit trails, electronic signatures, access control, data integrity, and periodic review.
• Run lifecycle and periodic reviews for products, processes, equipment, cleaning, computer systems, and temperature profiles on quality-critical equipment.
• Integrate validation into capital projects from URS through FAT, SAT, commissioning, and PQ.
• Use risk assessment to determine what actually requires validation and what doesn't, and document the rationale either way.
• Assess GMP impact through change control and management of change, and set revalidation requirements.
• Support CAPA teams, deviation investigations, and quality engineering investigations with validation data.
• Support HACCP study, Food Safety Plan, and process flow updates when the plant changes.
• Keep validation records audit-ready for FDA, SQF, USDA Organic, and customer audits, and stand in front of them during inspection.

Benefits

• Competitive stock options
• 401k with employer match
• Employee medical, dental, and vision insurance 100% covered by Bobbie, with options to add dependents through a subsidized pre-tax deduction
• 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
• One year subscription to Bobbie
• Subsidized meals and snacks provided on-site

What This Job Offers

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