Validation Engineering Specialist

HiFyve is hiring a Validation Engineering Specialist in the OTC and personal care industry in Eagan, MN!Salary: $67K - $90KShift: Day ShiftLocation: Eagan, MNPosition Overview:A well-established manufacturer in the OTC and personal care space is hiring a Validation Engineering Specialist to support qualification and validation activities for regulated products, including skincare and sunscreen formulations. This role is ideal for a validation professional who enjoys hands-on work, cross-functional collaboration, and ensuring compliant, reliable manufacturing processes.Key Responsibilities:Execute facility, utility, and equipment qualificationsSupport process validation and performance qualification (PQ/PPQ) activitiesLead and support cleaning validation and computer system validation effortsPartner with Quality, Production, and Engineering teams on validation initiativesSupport SOP updates, training, and validation documentationAssist with pFMEAs, process trials, pilot batches, and validation runs for new formulationsPrepare validation reports, metrics, and project updatesEnsure compliance with cGMP, FDA regulations, OTC monographs, and internal quality standardsSupport audits, risk assessments, corrective actions, and equipment qualificationKnowledge, Skills, and Abilities:Bachelor's degree in Chemistry, Physical Sciences, or a related field3+ years of validation experience in pharmaceutical and/or personal care manufacturingAt least 1 year of experience in Rx or OTC manufacturing environmentsWorking knowledge of equipment, utility, process, cleaning, and computer system validationStrong understanding of cGMP, FDA regulations, and OTC compliance requirementsAbility to manage multiple validation projects and deadlinesStrong documentation, communication, and cross-functional collaboration skillsHigh attention to detail and a proactive, problem-solving mindsetLean Six Sigma Green Belt or higher (Preferred)Experience supporting new product introductions or formulation scale-up (Preferred)