Operations Specialist
Core
Conduct process change impact assessments and support pilot plant operations to ensure compliance and efficiency in a regulated manufacturing environment.
Role type
Operations Specialist (R&D)
Builds
Pilot-scale products, research prototypes, and process improvements for nutrition products
Domain
Healthcare / Nutrition / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, change management, risk assessment, root cause analysis, data analysis, process optimization, scale-up support, SOP development, CAPA implementation
Preferred skills
Predictive modeling, AI-enabled tools, digital transformation, continuous improvement methodologies
Technologies
Microsoft Office Suite (Word, Excel, PowerPoint), AI-enabled tools, predictive modeling software
Responsibilities
Support manufacturing operations to ensure compliance with global quality standards and GMP requirements; Lead and maintain the APP GMP program; Participate in risk assessments and support the development of SOPs; Support investigations of safety and quality events; Analyze process and manufacturing data to identify trends; Support pilot plant trials and scale-up activities; Support APP Process Engineer in Technical Review Board activities; Support the application of predictive models and digital tools; Contribute to continuous improvement initiatives.
Seniority
Mid-level, hands-on IC
