Validation Engineering Specialist

HiFyve is hiring a Validation Engineering Specialist in the OTC and personal care industry in Eagan, MN!

Salary: $67K - $90K

Shift: Day Shift

Location: Eagan, MN

Position 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 qualifications
• Support process validation and performance qualification (PQ/PPQ) activities
• Lead and support cleaning validation and computer system validation efforts
• Partner with Quality, Production, and Engineering teams on validation initiatives
• Support SOP updates, training, and validation documentation
• Assist with pFMEAs, process trials, pilot batches, and validation runs for new formulations
• Prepare validation reports, metrics, and project updates
• Ensure compliance with cGMP, FDA regulations, OTC monographs, and internal quality standards
• Support audits, risk assessments, corrective actions, and equipment qualification



Knowledge, Skills, and Abilities:

• Bachelor’s degree in Chemistry, Physical Sciences, or a related field
• 3+ years of validation experience in pharmaceutical and/or personal care manufacturing
• At least 1 year of experience in Rx or OTC manufacturing environments
• Working knowledge of equipment, utility, process, cleaning, and computer system validation
• Strong understanding of cGMP, FDA regulations, and OTC compliance requirements
• Ability to manage multiple validation projects and deadlines
• Strong documentation, communication, and cross-functional collaboration skills
• High attention to detail and a proactive, problem-solving mindset
• Lean Six Sigma Green Belt or higher (Preferred)
• Experience supporting new product introductions or formulation scale-up (Preferred)

If you are interested, please apply.