QA Validation Engineer - Equipment, Process & Lifecycle
Core
Execute qualification and validation activities for equipment, processes, and systems to ensure compliance with quality and regulatory standards in a regulated manufacturing environment.
Role type
Validation Engineer (Equipment, Process & Lifecycle)
Builds
Validated manufacturing equipment, processes, and systems for nutritional products
Domain
Food technology / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP knowledge, validation protocol development, risk assessment (FMEA), change control management, analytical problem-solving, multidisciplinary collaboration
Preferred skills
IQ/OQ/PQ execution, automated manufacturing systems experience, food/pharma/medical device industry background
Technologies
IQ/OQ/PQ documentation, FMEA, change control systems
Responsibilities
Coordinate and execute equipment qualification and validation activities; Develop and review validation protocols and reports (IQ, OQ, PQ); Support change control activities for validated systems; Participate in risk assessments and FMEA activities; Collaborate with Engineering, Operations, and QA to implement compliant changes; Monitor validation status and ensure timely completion of deliverables; Support audits and inspections with validation expertise
Seniority
Mid-level, hands-on IC