Validation Engineer

Location: US-CO-Frederick; onsite work at Colorado manufacturing facilities. Occasional travel required.

Salary: $82,480–$128,875 per year, plus eligibility for bonus, stock, and benefits.

Company

hirify.global's Advanced Therapeutics Division is a contract development and manufacturing organization providing products and services for medicines, including oligonucleotide-based therapeutics.

What you will do

• Support commissioning, qualification, and validation activities across equipment, instruments, facilities, utilities, computerized systems, and cleaning processes.
• Generate, review, and execute validation plans, protocols, requirements, risk assessments, traceability matrices, reports, and related documentation.
• Manage or support laboratory-based cleaning validation studies, including method verification, cleanability studies, surface recovery, sprayball coverage, and cycle development.
• Execute validation studies with Engineering, Facilities, Manufacturing, Process Development, Quality Control, Quality Assurance, and Information Technology.
• Support factory and site acceptance testing, facility qualification, periodic reviews, and ongoing validation of manufacturing and QC systems.
• Investigate and resolve CAPAs, nonconformances, protocol incidents, change controls, equipment-cleaning issues, and audit requests.

Requirements

• Bachelor's degree or equivalent in engineering or life sciences.
• At least 1 year of relevant experience.
• Experience with validation programs, nonconformance investigations, CAPA, and change control.
• Knowledge of pharmaceutical manufacturing processes, quality improvement, and efficiency.
• Knowledge of FDA and international regulations, including 21 CFR, ICH Q7, cGMP, and GAMP requirements.
• Strong quality orientation, communication skills, attention to detail, ethical standards, and ability to work independently in a fast-paced team environment.

Culture & Benefits

• Full-time day-shift schedule with no specified end date.
• Opportunity to contribute to the growing oligonucleotide DNA-RNA therapeutics industry.
• Bonus, stock, and employee benefits eligibility.
• Inclusive, equal-opportunity workplace with reasonable accommodations available.