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.

Join a purpose‑built, agile small molecule manufacturing site where your work helps bring important medicines to patients in the U.S. The facility focuses on quality, safety, and operational excellence, receiving technology transfers from commercialization sites to fast‑follow into production.

• Support the Capital Project Team in design, commissioning, qualification, and startup readiness.
• Apply subject matter expertise on API processing unit operations and scale‑up opportunities to identify and overcome constraints.
• Take ownership of assigned process equipment and manufacturing processes.
• Support technology transfer and validation activities (e.g., pre‑PPQ, PPQ).
• Analyze process data for performance monitoring, troubleshooting, and improvement.
• Provide on‑the‑floor technical support during manufacturing campaigns.
• Execute 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 integrating new technologies into manufacturing operations.
• Identify and implement improvements in process robustness, product quality, and plant performance.
• 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.
• Collaborate closely with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams to provide technical input on projects and ongoing operations.

• Bachelor’s Degree in Chemical or Process Engineering or related discipline.
• Typically 1–4+years of experience in API manufacturing, process development, or a related pharmaceutical environment.
• Exposure to API processing operations and scale‑up.
• Understanding of cGMP manufacturing and regulatory expectations.
• Experience in process support or development, technology transfer, and manufacturing operations.

Salary range: $71,900.00–$. The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable. We offer a comprehensive benefits package that includes medical, dental, vision, health‑care, and other insurance benefits for employees and families; retirement benefits with 401(k) match; paid holidays; vacation; and compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.