Associate Process Engineer, Technical Operations - Molecule Drug Substance

Job Description

We have an exciting opportunity for an Assoc. 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 technical expertise and contributing to operational excellence.

• Support the Capital Project Team, contributing to design, commissioning, qualification, and startup readiness.
• Apply knowledge and subject‑matter expertise on API processing unit operations and scale‑up opportunities to identify and overcome constraints and tests, ensuring successful demonstration of processes through piloting and validation.
• Take ownership of assigned process equipment and manufacturing processes.
• Support technology transfer and validation activities (e.g., pre‑PPQ, PPQ).
• Analyse 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 Commercialization and external 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.

• Identify and implement improvements in process robustness, product quality, and plant performance.
• Demonstrate aptitude for technical problem solving, obtaining positive outcomes.
• Contribute to cleaning and turnaround optimisation activities.
• Assist in deviation investigations, root cause analysis, and implementation of CAPAs.
• Monitor process performance, yields, and cycle times to identify improvement opportunities.

• Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards.
• Participate in campaign preparation, safety and environmental reviews, batch sheet reviews.
• Support campaign preparation, execution, and post‑campaign review activities.
• Support batch record generation, review, and ongoing optimisation.
• 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.
• Communicate effectively across boundaries, conveying complex projects to people at all levels of the organization in a compliant manner.

• Bachelor’s Degree in Chemical,…