(Sr./Lead) Engineer, Process
Core
Lead process engineering projects for CDC and PP Packing streams to deliver formulation/packing projects on time, ensuring process robustness and supporting autonomous manufacturing and zero carbon goals.
Role type
Senior Process Engineer (Pharmaceutical Manufacturing)
Builds
Pharmaceutical production processes, validation protocols, and technical transfer deliverables for oral solid dosage and packing operations.
Domain
Pharmaceutical manufacturing (Oral Solid Dosage, Blister & Bottle Packing)
Required skills
Process validation, Cleaning validation, GMP compliance, Experimental Design (DoE), Statistical analysis, Project management, Technical transfer, Change control management, Root cause analysis, Continuous improvement (CPV), Regulatory knowledge
Preferred skills
Lean concepts, Risk-based assessment, Supplier selection, FAT/SAT coordination, Training delivery
Technologies
GMP, QSR, SVMP, VMP, VP, EBPR, SOP, Change Control, CPV, CMA, CQA, CPV, DoE, DOE
Responsibilities
Design and conduct qualification, process validation, and cleaning validation; Lead new technical project deliverables including material source change and technical transfer; Author production documents (Batch sheet, SOP, Validation protocols); Solve complex technical issues to enable process robustness; Drive continuous improvement of process robustness; Act as technical coach to support capability uplift of process, manufacturing, and quality teams; Manage qualification and validation related change activities; Update validation master plans and coordinate QSR implementation.
Seniority
Senior, hands-on IC
