Senior Validation Engineer
Core
Lead validation engineering for commissioning, qualification, cleaning validation, and lifecycle maintenance of manufacturing systems and equipment in a pharmaceutical facility.
Role type
Senior Validation Engineer (Manufacturing)
Builds
Validated manufacturing systems, equipment, and processes for new product introductions and facility upgrades.
Domain
Pharmaceutical Manufacturing / GMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment qualification, cleaning validation strategies, regulatory compliance (GMP), root cause analysis, validation lifecycle management, change control, technical writing, cross-functional coordination, mentorship
Preferred skills
Small molecule manufacturing unit operations, controlled temperature chamber (CTC) validation, steaming validation (autoclaves), regulatory submission support, complex validation investigations
Technologies
COTS units, Controlled Temperature Chambers (CTC), Autoclaves, Manufacturing Execution Systems (implied by context of validation)
Responsibilities
Establish validation strategies and procedures aligning with regulatory expectations; coordinate with Manufacturing, Engineering, and Quality to meet validation requirements; lead cleaning validation activities including strategy generation and report approval; oversee validation tasks for equipment commissioning and qualification; maintain site validation master plans and monitor regulatory compliance; mentor cross-functional team members; drive continuous improvement initiatives within the validation workspace.
Seniority
Senior, hands-on IC with team leadership
