Product and Process Engineer & Packaging
Core
Principal point of contact for product knowledge, end-to-end process, and packaging technologies for oral solid dosage formulations (tablets, capsules, powders).
Role type
Senior Product and Process Engineer (Packaging)
Builds
Validated manufacturing and packaging processes for consumer health products
Domain
Consumer Health / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing science, packaging equipment technology, change control management, continued process verification (CPV), product control strategies (PCS), technical risk assessments (TRA), process validation, root cause analysis, project management, SAP systems
Preferred skills
FDA/GMP regulations, regulatory requirements for packaging, production forecasting, problem solving, SAP, eBR, Serialization, Workday, Veeva, MyLearning, Office
Technologies
SAP, eBR, Serialization, Workday, Veeva, MyLearning, Office
Responsibilities
Lead or contribute to change controls impacting products or manufacturing processes; Implement and maintain continued process verification (CPV) for products and packaging; Maintain and review product control strategies (PCS) and technical risk assessments (TRA); Provide information to develop and execute process validation; Lead resolution of packaging issues and risks; Act as the "voice of packaging" for the site; Collaborate on material simplification and productivity projects; Manage compliance records including deviations and CAPAs; Support responsible person for complaints during investigations.
Seniority
Senior, hands-on IC
