Técnico PPLM (Product & Process Lifecycle)
Core
Lead Product & Process Lifecycle Management for products manufactured on site, ensuring validated processes and compliance with health authority standards.
Role type
Senior IC manufacturing validation technician
Builds
Validated manufacturing processes and cleaning states for consumer health products
Domain
Pharmaceutical manufacturing / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
process validation, cleaning validation, change control management, deviation/CAPA management, project management, data analytics, statistics, problem-solving tools
Preferred skills
plant operations experience, FDA/GMP regulation implementation, SAP systems proficiency, production forecasting
Technologies
SAP, eBR, Serialization, Workday, Veeva, MyLearning, Office
Responsibilities
Maintain site product/process & cleaning state against existing matrices; prepare and maintain site validation master plan (SVMP); ensure validation activities are completed on time and compliant; prepare and review technical documentation (trials, TRA, PCS, investigations); own and manage compliance records (deviations, CAPAs, change controls); lead improvement projects related to manufacturing processes; support investigations of complaints; identify risks related to Technical, Safety, Quality, and Supply.
Seniority
Mid-level, hands-on IC