Validation Engineer
Tri-Pac IncSouth Bend, Indiana, United States
Posted July 30, 2025
Full Time
About the Company
Tri Pac, Inc. is a Contract Development & Manufacturing Organization (CDMO) specializing in compounding, manufacturing, and filling of topicals, orals, skincare, and haircare products for various formats. With extensive certifications including ISO 13485, UL Health Canada OTC, and FDA registration, Tri Pac offers a comprehensive range of services from turn-key product development to regulatory compliance and quality assurance. The company's focus on innovation, supply chain management, and environmental sustainability positions it as a reliable partner for the OTC, consumer healthcare, cosmetic, and medical device industries.
Job Description
Tri-Pac, Inc. is seeking a Validation Engineer to work in a matrix team environment, influencing team decisions and exercising sound judgement in determining compliant and robust validation approaches. The candidate will have experience in biologics manufacturing processes, including fermentation, purification, and bulk filling processes, and must have good interpersonal, verbal, and written communication skills.
Requirements
- Bachelor's Degree in Engineering or Science discipline
- Minimum 5+ years of relevant validation experience in regulated industry
- Expertise in Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, computer system validation and Process Validation
Benefits
- Competitive Salary/ Pay & Packages
- Vacations
- Insurance
- 401K
- Life Insurance
- Disability (Long term/ Short term)
- Continuous Training
- Education Assistance
