Process Engineer, Technical Operations - Small Molecule Drug Substance
About The Position
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’ll 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. The successful candidate will provide technical support for the facility design, commissioning, qualification through technology transfer, validation and ongoing commercial manufacture of active pharmaceutical ingredients (APIs). In this role, you will work as part of a cross-functional team, initially supporting the capital project and transitioning to technology transfer and commercial manufacturing, while building deep technical expertise and contributing to operational excellence.
Requirements
- 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
- Strong analytical and problem-solving capability
- Ability to analyze data and make sound technical decisions
- Effective communication and collaboration across cross-functional teams
- Ability to manage priorities, meet deadlines, and deliver quality outcomes
- Proactive, self-driven approach to continuous improvement
Responsibilities
- 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
- 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
- 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
- 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
- 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
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
