The Process Engineer III leads the technical transfer, scale‑up, and implementation of drug substance biologics processes from development into GMP manufacturing. Operating with minimal direction, this senior role applies advanced engineering principles and continuous improvement methodologies to ensure operational readiness. The position serves as a cross‑functional lead and coach—fostering Lean Six Sigma, Change Management, and Inclusion across internal teams and CDMO partners.
Key Responsibilities
Technical Transfer & Process Engineering
Lead Product Transfers: Drive end‑to‑end tech transfer and introduction of new drug substance processes (upstream/downstream).
Process Scale‑Up: Partner with Development to transfer process knowledge (CPPs/CQAs); provide technical oversight for scale‑up, engineering runs, and PPQ validation campaigns.
Documentation: Generate and approve critical transfer documents (process descriptions, mass balances, BOMs, protocols, and reports).
Drive Process Excellence: Identify, prioritize, and execute technical and business process improvements using Lean Six Sigma and Change Management tools.
Coaching & Culture: Facilitate kaizens, lead optimization projects, and coach sponsors/practitioners while actively championing Inclusion and data‑driven decision‑making.
Investigations & Cross‑Functional Alignment
Deviation & CAPA Ownership: Steer complex, cross‑functional investigations into manufacturing deviations, defining robust root causes and CAPAs.
Project Governance: Lead matrixed transfer teams and manage communications with internal stakeholders and CDMOs to mitigate technical and timeline risks.
Required Qualifications
Education: Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, or a related discipline.
Experience: Typically 5–8+ years in biologics process engineering, MSAT, or tech transfer.
Autonomy: Highly skilled specialist capable of executing complex projects with minimal work direction.
Methodologies: Proven experience applying Lean Six Sigma and Change Management tools to technical operations.
Compliance: Strong understanding of cGMP regulations, validation life cycles, and quality systems (deviations, CAPAs, change controls).
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