Manufacturing Process Expert
Core
Advanced root cause analysis expert driving quality excellence, error prevention, and continuous improvement for sterile injectable manufacturing operations.
Role type
Manufacturing Process Expert (Quality/Technical Investigation)
Builds
Corrective and Preventive actions (CAPA), deviation resolutions, and process improvements for injectable sterile products.
Domain
Pharmaceutical manufacturing (injectable sterile) + Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, deviation management, CAPA implementation, GMP compliance, cross-functional team coordination, technical process knowledge, risk mitigation, audit support, documentation handling
Preferred skills
TapRoot tool proficiency, TrackWise system expertise, sterile process manufacturing knowledge, planning and organization
Technologies
TrackWise, TapRoot
Responsibilities
Facilitate and perform advanced root cause analysis for complicated technical problems; manage deviations and guide CAPA definition with cross-functional teams; execute technical analysis inside and outside the Technical Unit; coordinate cross-functional investigation teams; utilize manufacturing process knowledge to identify and resolve manufacturing issues; support implementation of CAPA with Quality Specialists; proactively identify and mitigate risks; share lessons learned during technical unit huddles; utilize investigation skills during client and regulatory audits.
Seniority
Mid-level, hands-on IC
