Director, Engineering, Technical Expert Sterile Fill
Core
Provides enterprise-level technical leadership for biologics sterile fill engineering, ensuring Annex 1-aligned contamination control, aseptic processing design, and GMP readiness across strategic investment portfolios.
Role type
Director, Engineering Technical Expert Sterile Fill
Builds
New manufacturing facilities, technology platform deployments, capacity expansion, and lifecycle asset renewal for biologics sterile fill.
Domain
Biopharmaceuticals / Sterile Manufacturing / Engineering Governance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure (manufacturing facilities and equipment)
Required skills
Sterile fill engineering, Annex 1 compliance, aseptic processing design, contamination control strategy, barrier technology strategy, GMP readiness, validation/CQV integration, technical assurance, capital program leadership, cross-functional stakeholder management
Preferred skills
Experience with isolators, restricted access barrier systems, Grade A critical zones, unidirectional airflow, first-air protection, glove systems, transfer systems, lyophilization interfaces, single-use systems
Technologies
Isolators, Restricted Access Barrier Systems (RABS), Grade A/B/C/D cleanrooms, Unidirectional Airflow (UA), First-Air Protection, Glove Systems, Transfer Systems, Lyophilization, Single-Use Systems
Responsibilities
Establish global engineering standards for biologics sterile fill; Lead technical decision-making for new facility builds and technology platform deployments; Govern contamination control strategy and aseptic process design; Partner with Quality and Validation teams for GMP readiness; Drive capability building and knowledge sharing across the enterprise.
Seniority
Director, strategic leadership & enterprise governance