Validation Engineer I
Core
Planning, executing, and documenting validation activities for equipment, processes, and computer systems to ensure product quality and regulatory compliance.
Role type
Validation Engineer I
Builds
Validated equipment, processes, and computer systems for scientific instruments and laboratory solutions
Domain
Life Sciences / Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation principles (IQ/OQ/PQ), FDA/EMA regulatory knowledge, risk assessment methodologies, data integrity (21 CFR Part 11), equipment qualification, process validation, cleaning validation, contract management, GMP adherence
Preferred skills
Engineering, Chemistry, Biotechnology, Biology, or related scientific field
Responsibilities
Develop and execute Validation Master Plans, perform risk assessments, manage validation documentation and protocols, oversee contractor activities, ensure compliance with GMP and safety standards
Seniority
Entry-level IC
