Formulation Process Engineer

Description:

The Senior Process Engineer in sterile manufacturing will ensure the compliant, efficient, and safe transfer of new products, implementing manufacturing processes from concept to launch, including scaling up and aseptic process simulation. The position will lead continuous improvement initiatives and support process discrepancies. The role serves as Subject Matter Expert (SME) for providing technical expertise for sterile/aseptic, filling and packaging technologies, formulation, Lyophilization, depyrogenation and root cause analysis.

Essential Functions:

• Develop, author, and execute protocols to ensure compliance with FDA and cGMP requirements, including process validation, cleaning validation, and automated system and control qualification. Monitor, interpret, and analyze manufacturing data to support the full process lifecycle, identifying opportunities for improvement and facilitating investigations to resolve process deviations and anomalies.

• Develop and manage technical plans, project scopes, design suitability studies, and implementation schedules to establish manufacturing process capability and support the introduction of new or reformulated products. Conduct feasibility assessments, risk analyses, budgeting, and project execution in alignment with business objectives. Collaborate closely with R&D and Manufacturing teams to transition processes from development to scale‑up and full commercial production. Evaluate and implement new technologies to strengthen and expand manufacturing capabilities.

• Provide real‑time troubleshooting for complex manufacturing equipment failures and process deviations, ensuring prompt resolution to maintain operational continuity. Lead personnel training, develop manufacturing instructions, and support the start‑up of new processes and equipment. Monitor key performance indicators—including quality, yield, throughput, cycle time, and critical process parameters—to drive improvements and ensure compliance with cGMP, safety, and environmental requirements. Collaborate with vendors and suppliers to define system requirements and validate functional specifications for sterilization, decontamination, and environmental control systems.

• Serve as a Subject Matter Expert (SME) by providing advanced technical expertise across key manufacturing processes, including chemical and biological formulation, filling, packaging, and contamination‑control operations. Develop and revise SOPs, ensuring alignment with regulatory and operational requirements. Lead and manage change controls and conduct impact assessments to support compliant process modifications. Support and lead investigations to determine root causes, perform data analysis, and drive effective CAPA implementation. Contribute to the creation and revision of process documentation and batch records to ensure accuracy, compliance, and continuous improvement.

Additional Responsibilities:

• Verify and develop P&ID, engineering layout, engineering drawings and engineering documents.

• Employ key project management principles including establishing and tracking timelines, identifying and mitigating risks, and communicating across teams at all levels.