Validation Engineer

Location: Dallas, Texas, United States

Company

hirify.global manufactures specialty materials, engineered components, and solutions for filtration, healthcare, sustainable packaging, and other industrial applications.

What you will do

• Manage validation studies for manufacturing equipment, utilities, computerized systems, processes, and cleaning operations.
• Generate, review, and execute the site master validation plan and IQ, OQ, and PQ protocols.
• Prepare and manage change requests, validation documentation, deviations, corrective actions, and requalification records.
• Apply statistical process control and monitoring programs to maintain equipment and processes in a validated state.
• Investigate incidents, deviations, equipment issues, and non-conformances using troubleshooting, root cause analysis, and FMEA.
• Support audits, vendors, SOP updates, and cross-functional facilities, utilities, and equipment projects.

Requirements

• Bachelor’s degree in engineering, preferably chemical engineering, life sciences, or a related field.
• At least 3 years of validation experience in the pharmaceutical or medical device industry.
• Experience authoring and executing equipment and installation validation protocols.
• Strong knowledge of FDA regulations, cGMP, ISO 13485, ICH guidelines, and risk management principles.
• Strong problem-solving, communication, documentation, and technical analysis skills.
• Ability to work independently and in cross-functional teams in a fast-paced environment.

Nice to have

• Experience with cleaning, software, automated systems, packaging, and laboratory equipment validation.
• Certified Quality Engineer or validation professional certification.
• Experience with validation software, statistical analysis, Six Sigma, SOP writing, and technical writing.
• Experience leading continuous quality system improvements.

Culture & Benefits

• Work with cross-functional partners, customers, supervisors, vendors, and colleagues across different states and countries.
• Benefits provide multiple coverage and support options for employees and their families.
• Work in a global manufacturing organization operating across three continents and nearly 100 countries.