Process Engineer, Technical Operations - Molecule Drug Substance

Process Engineer, Technical Operations
- Drug Substance

We have an exciting opportunity for a Process Engineer, Technical Operations
- Drug Substance to join our growing team.

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.

At our site, you will be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

Technical & Process Support

• Support the Capital Project Team, contributing to design, commissioning, qualification, and startup readiness.
• Provide technical support for API manufacturing processes, including:
  • Chemical synthesis
  • Purification and isolation
  • Crystallization and drying operations
• Take ownership of assigned process equipment and manufacturing processes.
• Support process scale‑up, technology transfer, and validation activities (e.g., pre‑PPQ, PPQ).
• Analyze process data to support performance monitoring, troubleshooting, and improvement.
• Provide on‑the‑floor technical support during manufacturing campaigns.

Technology Transfer & Commercialization

• Support execution of technology transfers for new products and processes into the facility.
• Partner with global R&D and receiving sites to ensure effective process knowledge transfer.
• Contribute to process fit assessments, scale‑up readiness, and manufacturability evaluations.
• Support development and review of batch documentation and process instructions.
• Assist in integration of new technologies into manufacturing operations.

Process Optimization & Operational Excellence

• Partner with Manufacturing to support safe, efficient, and reliable plant performance.
• Identify and implement improvements in process robustness, product quality, and plant performance.
• Support activities related to operational excellence and cost reduction.
• Contribute to cleaning and turnaround optimization activities.
• Assist in deviation investigations, root cause analysis, and implementation of CAPAs.
• Monitor process performance, yields, and cycle times to identify improvement opportunities.
• Drive or participate in continuous improvement initiatives focused on:
  • Yield and throughput
  • Cycle time reduction
  • Cost and efficiency improvements

Compliance & Documentation

• Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards.
• Support campaign preparation, execution, and post‑campaign review activities.
• Support batch record generation, review, and ongoing optimization.
• Assist in regulatory and inspection readiness activities.
• Ensure accurate documentation of process knowledge, investigations, and improvements.

Cross‑functional Collaboration

• Work closely with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams.
• Provide technical input into projects, process changes, and ongoing operations.
• Participate in cross‑functional teams supporting product introduction and lifecycle management.

To excel in this role, you will have:

• Degree in Chemical Engineering, Chemistry, or related discipline.
• Typically 2‑5+ years’ experience in API manufacturing, process development, or related pharmaceutical environment (PhD may offset experience).
• Exposure to API processing operations and scale‑up.
• Understanding of cGMP manufacturing and regulatory expectations.
• Experience in one or more of:
  • Process support or development
  • Technology transfer
  • Manufacturing operations
• Stron…