Validation Engineer

About Bobbie 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. Bobbie for Change 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 A good fit if… You've written a protocol you were later asked to defend, and it held You know the difference between validating something and generating paper about it You can tell a project engineer "no, not yet" and keep the relationship You want infant formula on your résumé because you think it's the work worth doing What the Heath plant is actually like Regulated infant formula facility under 21 CFR 106/107 — FDA inspects, and validation records are central to what they read Wet processing, spray dry, and canning, plus utilities — broad validation scope for one person A young quality system: you'll be writing first versions, not editing tenth versions Active production, so protocol execution has to be scheduled around running lines and sometimes off-shift What we would like you to have 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 Experience with 21 CFR 106/107 (infant formula) and 21 CFR 113 (thermally processed low-acid foods) strongly preferred 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 PCQI, HACCP certification, Better Process Control School, ASQ CQE or CQA, or SQF Practitioner certification are all a plus The honest picture: Regulated infant formula facility. FDA inspects. Concrete floors, loud equipment, continuous production. You gown in every shift — hair net, no jewelry, no nail polish, no fragrances, dedicated footwear. No phone on the floor. You are the validation function here — there is no team behind you yet, and the backlog is real. You'll be writing first-version documents under project deadlines, and you'll be in the room when FDA asks about them. If you want to inherit a mature validation program and execute someone else's protocols, this isn't that role — and that's okay to know before you apply. Why Bobbie We're a parent-founded company that makes organic infant formula in the US. We opened our Heath, Ohio facility because we believe families deserve to know who makes their baby's food and how. The people who run this plant are the reason every can meets the standard. Work that matters — the standard you set is the standard a parent trusts when they open the can Ownership of an entire site validation program, with the mandate to build it properly the first time We promote from within and invest in people who invest in us You’re inspired by our core values: Be Radical • We are change makers, rule breakers and stigma shakers. We are unapologetically bold and use our megaphone for good. Nurture the Tension • Parenthood is full of healthy tension, and so is building a company. We embrace the unknowns, practice humility and are a culture of learners. Deliver Ounce by Ounce • Our customers have entrusted us to feed their babies. We lose sleep over the details, so they don’t have to. Don’t Assume • We embrace our unique perspectives, withhold judgment, and find beauty in the paths that brought us all to Bobbie. Our strength is celebrating each other and our collective voice. Compensation and Benefits: Compensation  Our salaries are based on paying competitively for our size and industry. The salary range for this position is $95,000-$110,000. 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 At Bobbie, we are committed to building a diverse and inclusive company. We seek to create a culture where everyone can belong because we believe that people do their best work when they can show up every day as their authentic selves. We welcome people of different backgrounds, experiences, abilities, and perspectives. Bobbie is an equal opportunity employer. We do not make hiring or employment decisions on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, veteran status, disability status or genetic information, in compliance with applicable federal, state and local law. Bobbie Personnel Privacy Policy and Notice at Collection