Validation Engineer

Bobbie makes European-style organic infant formula manufactured end-to-end in the U.S., because we believe every parent deserves to feed their baby with confidence, without judgment and without compromise. No mystery ingredients. No shortcuts. Just clean, thoughtfully made formula that parents can trust.

But Bobbie has never been just a formula company. When the 2022 national infant formula shortage left parents across the country unable to feed their babies, we closed our storefront to new customers rather than leave a single existing family without formula. We went to Washington. We got loud. And we opened our Heath, Ohio manufacturing facility to make sure something like that could never happen again.

That's who we are, and that's what you'd be joining.

Our advocacy arm, Bobbie for Change, exists because making great formula isn't enough if the systems around parenthood are still broken. We fight for paid federal parental leave, push for legislation to prevent future formula shortages, advocate for feeding equity, and support families navigating impossible situations, including donating formula to parents impacted by breast and gynecologic cancers through the Bobbie Breasties program.

We're a company that genuinely believes becoming a parent makes you an activist. The people who work here feel that too.

The role

Infant formula is the most regulated food in America, and it should be. Validation is how we prove we've earned the trust.

You’ll own the validation program at our Heath facility — the Validation Master Plan, IQ/OQ/PQ for new and modified equipment, process validation, cleaning and CIP validation, thermal and temperature mapping, and computer system validation under 21 CFR Part 11. You'll write the protocols, execute them, report them, and defend them to an FDA investigator. When a project engineer wants to change something, you're the person who decides what that change costs in validation.

What you’ll own

• 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
• You’ve written a protocol you were later asked to defend, and it held
• You know the difference…