Job Description
Job Description
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.