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35467 Sr Engineer -Drug Substance Biotechnology/Pharmaceutical - BES Consulting Group, LLC
Software Engineer
Senior Engineer in Drug Substance Biotechnology leading GMP pharmaceutical process support, leveraging SAP, TrackWise, electronic batch records, and Veeva document management to ensure compliant manufacturing operations.
About the role
Key Responsibilities
- Provide technical engineering support for drug substance manufacturing processes, ensuring compliance with GMP standards.
- Configure and maintain SAP and TrackWise systems for batch record creation, change control, and audit readiness.
- Develop and update electronic batch records (PAS/X) and Veeva document management workflows.
- Collaborate with cross‑functional teams to troubleshoot process deviations and implement corrective actions.
- Prepare and review technical documentation, SOPs, and training materials for production staff.
Requirements
- Doctorate, Master’s, or Bachelor’s in Engineering with 4+ years of pharmaceutical engineering experience.
- Proven experience in drug substance process support and GMP manufacturing environments.
- Strong knowledge of SAP, TrackWise, electronic batch records, and Veeva systems.
- Fluency in English and Spanish, both written and verbal.
- Excellent analytical, problem‑solving, and communication skills.