Senior Process Engineer, Technical Operations – Molecule Drug Product; Oral Solid Dose

Senior Process Engineer, Technical Operations – Small Molecule Drug Product (Oral Solid Dose)

We are searching for a senior process engineer to lead technical operations for oral solid dosage drug products at our small‑molecule manufacturing site in the U.S. The role will span capital projects, technology transfer, commercial manufacturing, and continuous improvement, with a focus on quality, safety, and operational excellence.

• Provide technical leadership for manufacturing processes including blending, granulation, roller compaction, tablet compression, film coating, and finishing operations.
• Act as process owner/SME for assigned unit operations, equipment, or product processes.
• Support the capital project team with equipment selection, design reviews, commissioning, qualification, and startup readiness for oral solid dose lines.
• Lead or coordinate process scale‑up, technology transfer, and validation activities (e.g., process performance qualification).
• Analyze and interpret process and product data to drive data‑driven decisions and performance improvements.
• Provide advanced troubleshooting for compression, compaction, and coating issues.
• Partner with global R&D and network sites to ensure robust transfer of formulation and process knowledge.
• Develop and optimize master batch records, process descriptions, and control strategies.
• Implement continuous‑improvement initiatives aligned with operational excellence, using structured problem‑solving approaches (e.g., RCA, DOE).
• Ensure compliance with cGMP, safety, and environmental standards, and support regulatory inspections and audits.
• Act as a technical representative across Manufacturing, Quality, Engineering, Supply Chain, and R&D, driving alignment to site objectives.

• Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline.
• 5+ years of experience in oral solid dose manufacturing, formulation, or process development;
  PhD may offset experience.
• Strong experience with roller compaction, tablet compression, and film coating processes.
• Experience in process scale‑up, commercialization, technology transfer, and process validation (PPQ).
• Demonstrated troubleshooting expertise in tableting and coating in a commercial environment.
• Strong analytical capability with ability to interpret process performance data.
• Leadership experience in technical work streams or projects.
• Excellent problem‑solving skills and structured, science‑based approach.
• Effective communication and influence across cross‑functional stakeholders.
• Proactive, self‑driven mindset with focus on continuous improvement and ownership.

• Root Cause Analysis (RCA), Design of Experiments (DOE), process optimization, continuous manufacturing.
• Change control, deviation management, engineering standards, equipment selection, maintenance engineering.
• Strategic thinking, teamwork, operational excellence, regulatory compliance.

Our team commits to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We emphasize patient focus, innovation, and inclusive collaboration.

Salary range: $ – $. The successful candidate will be eligible for annual bonus and long‑term incentive, where applicable. Comprehensive benefits include medical, dental, vision, health insurance, retirement benefits, 401(k), paid holidays, vacation, and compassionate & sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants 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. We are a federal contractor and comply with all affirmative action requirements for protected veterans and individuals with disabilities.