Project Manager, Validation
Core
Lead and manage a diverse portfolio of validation projects (equipment qualification, process validation, cleaning validation, system digitization) for pharmaceutical manufacturing clients.
Role type
Senior IC validation project manager
Builds
Validation and FDA compliance documentation/protocols for pharmaceutical equipment and processes
Domain
Life sciences (pharmaceuticals) + engineering validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation of pharmaceutical/medical device processes and equipment, FAT/SAT/IQ/OQ documentation development and execution, project management, leadership, communication, computer skills
Preferred skills
Validation in automation, packaging, cleaning, computer systems, utilities, or facilities
Technologies
Automated Systems
Responsibilities
Prepare and execute commissioning and qualification documents for utility, facility, and process equipment; Serve as primary on-site point of contact and local engineering leader for major pharmaceutical manufacturing clients; Develop and execute validation and FDA compliance related documents/protocols
Seniority
Senior, hands-on IC
