Associate Process Engineer, Technical Operations - Molecule Drug Substance

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 a premier research‑intensive biopharmaceutical organization, using cutting‑edge science to improve lives worldwide. This small molecule manufacturing site focuses on operational excellence and rapid technology transfer from commercialization sites into production.

• Support the Capital Project Team, contributing to design, commissioning, qualification, and startup readiness.
• Provide technical support for API processing unit operations and scale‑up opportunities, identifying and overcoming constraints.
• Take ownership of assigned process equipment and manufacturing processes.
• Support technology transfer and validation activities (e.g., pre‑PPQ, PPQ).
• Analyze process data to support performance monitoring, troubleshooting, and improvement.
• Provide on‑floor technical support during manufacturing campaigns.
• Assist in the execution of technology transfers for new products and processes into the facility.
• Partner with commercialisation teams 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.
• 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 comply 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 complex projects across boundaries, conveying information to all levels.

• Bachelor’s degree in Chemical or Process Engineering or related discipline.
• Typically 1–4+ years of experience in API manufacturing, process development, or 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, or manufacturing operations.
• Strong analytical and problem‑solving capability.
• Ability to analyse 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.

• US and Puerto Rico Residents Only.

Salary range: $71,900.00 – $ (based on education, experience, geographic location, and business needs).

Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days, and an annual bonus/long‑term incentive, if applicable.

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 legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.