Expert Process Manufacturing Support
Core
Drive continuous improvement, engineering, and Qualification/Validation (Q/V) initiatives in a cGxP pharmaceutical manufacturing environment.
Role type
Expert Process Manufacturing Support (Continuous Improvement & Q/V)
Builds
Pharmaceutical specialties for neurological disorders, immunology, allergies, epilepsy, and autoimmune diseases
Domain
Biopharmaceutical manufacturing (cGxP)
Required skills
Lean/Kaizen methodologies, cGxP compliance (FDA/EMA/ASTM E2500), Process Validation, Gap Assessment, SOP drafting, KPI analysis, Risk Analysis, Data Integrity, Cross-site harmonization
Preferred skills
Shop floor troubleshooting, Stakeholder engagement, Project management
Technologies
None explicitly stated
Responsibilities
Drive continuous improvement (Lean/Kaizen) to optimize processes and eliminate waste; Support Engineering, Qualification, and Process Validation (Q/V) activities; Lead cross-site process and tool harmonization; Perform gap assessments against global standards; Support quality digitalization and data integrity; Draft and update SOPs and quality documentation; Establish and analyze KPIs for Manufacturing Support; Engage on the shop floor to troubleshoot and coach users
Seniority
Senior, hands-on IC
