Process Engineer - Urgently Hiring!

Process Engineer

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Purpose and Scope :

The Process Engineer is responsible for providing technical support to help ensure the successful deployment of new equipment, single-use systems, and processes; support and troubleshoot existing equipment and systems for pre-clinical through commercial manufacturing processes for drug substance; and assist in the technical transfer of processes from small / lab scale to large / commercial scale and from external partners.  The role is also responsible for effective collaboration with Manufacturing, Automation, Supply Chain, Warehouse, Technical Development, Quality, Regulatory, Facilities, Validation, and various vendors.  This role is based in Sanford, NC.

Essential Job Responsibilities :

• Provide process engineering, design, and on-going improvements for drug substance manufacturing processes
• Process subject matter expert in either upstream or downstream drug substance manufacturing with ability to support multiple modalities
• Matrix leadership of cross-functional teams to define and implement a robust process control strategy commensurate with program phase from pre-clinical through commercialization
• Support Single-Use (SU) program development and execution and consumable design and material qualification in collaboration with internal and external partners
• Evaluate new technologies that will enhance control of production processes and help coordinate deployment across the manufacturing network as appropriate and
• Interact closely with vendors for SU materials and equipment procurement, as well as new technology implementation
• Routine trending of process data to enhance process understanding, proactively identify gaps and issues, and implement process improvements
• Author and review process descriptions, standard operating procedures, technical reports, risk assessments, campaign summary reports, health authority briefing documents, submissions, and responses, tech transfer plans / reports, PPQ protocols / reports, process control strategy, and engineering study protocols / reports
• Support / lead tech transfer, equipment commissioning, training, and validation activities
• Provide on-the-floor support to implement improvements for process, equipment, or operational procedures including evaluation and testing of new technologies, new operating strategies, and process and equipment troubleshooting for GMP manufacturing
• Support recipe generation and updates for process equipment such as bioreactors, chromatography systems, and TFF systems
• Support process deviation investigations, root cause analysis, and CAPAs
• Support product lifecycle management that incorporates phase appropriate requirements and expectations from pre-clinical through commercialization and drives process optimization and cost of goods reduction
• Will support and demonstrate data integrity standards to ensure data of highest quality