Validation - Engineer (m/f/d) (Remote)

Location: Remote, United States

Company

hirify.global provides Laboratory Information Management Systems, Manufacturing IT, and Quality Assurance consulting solutions for pharmaceutical and biotech organizations.

What you will do

• Lead planning, execution, and documentation of validation activities for computerized systems, equipment, and manufacturing processes.
• Create and review validation plans, requirements, specifications, risk assessments, IQ/OQ/PQ test protocols, and summary reports.
• Implement paperless validation solutions using Kneat, Valgenesis, Polarion, DevOps, Jira, and automated testing tools.
• Support QMS modernization, Pharma 4.0 adoption, quality control, and QA IT initiatives.
• Collaborate with MES, LIMS, and SAP specialists to validate integrated enterprise systems.
• Mentor team members and clients and provide expert support during audits and inspections.

Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Computer Science, or a related field.
• At least 3 years of validation engineering experience in pharmaceutical, biotech, or regulated life sciences environments.
• Strong knowledge of GMP, GLP, GxP, GCP, GAMP5, and computer system validation using CSV/CSA approaches.
• Hands-on experience with paperless validation platforms such as Kneat, Valgenesis, and Polarion, plus DevOps, Jira, or automated testing tools.
• Technical writing skills and experience producing validation documentation and deliverables.
• Ability to lead validation projects and communicate effectively in consulting and in-house environments.

Culture & Benefits

• Transparent and equitable work policies.
• Remote work infrastructure and tools for collaboration.
• Start-up environment focused on innovation, continuous learning, and new technologies.
• Trust-based culture with empowerment and constructive feedback.
• Career development plans, early responsibility, and opportunities to lead impactful projects.
• Flexible arrangements supporting work-life balance.