remote
Sr. Engineer - Weil Group, Inc
Software Engineer
Senior Engineer leading biotech pharmaceutical process projects, driving GMP compliance, SAP integration, and electronic batch record systems to optimize drug substance manufacturing.
About the role
Key Responsibilities
- Lead end‑to‑end development of process optimization strategies for drug substance manufacturing.
- Design, implement, and maintain SAP and TrackWise workflows to support GMP pharmaceutical production.
- Oversee electronic batch record (PAS/X) creation, validation, and audit readiness.
- Collaborate with cross‑functional teams to integrate Veeva document management into the manufacturing lifecycle.
- Mentor junior engineers and drive continuous improvement initiatives across the production environment.
Requirements
- 10+ years in biotechnology or pharmaceutical process support with a focus on drug substance manufacturing.
- Deep knowledge of GMP regulations and experience with SAP, TrackWise, and Veeva systems.
- Proven track record in designing and validating electronic batch record solutions.
- Strong analytical, problem‑solving, and communication skills.
- Ability to thrive in a fast‑paced, global impact environment.