Manufacturing Process Specialist

Role Summary

The Manufacturing Process Specialist is responsible for providing technical expertise in the manufacturing of biological products on-site and across the network.

• Provide technical expertise to ensure atypical event and non-conformance investigations are completed in compliance with all applicable procedures and regulations.
• Monitor and trend key process parameters.
• Troubleshoot manufacturing problems as required and provide primary technical support on the production floor.
• Identify and implement process improvements locally and across the network.
• Support capital projects, site-wide initiatives, or other projects as a project manager or subject‑matter expert.
• Conduct technical and validation studies.
• Provide primary production support and technical assistance for the investigation and resolution of deviations and atypical events.
• Partner with the primary investigator to ensure consistent quality standards are maintained.
• Identify true root causes of investigations and assess product quality impact.
• Approve investigations as the management technical representative of Cell or COE, as needed.
• Recommend, own, and implement corrective/preventative measures to improve compliance and reduce repeat occurrences.
• Follow up to determine if corrective actions adequately address root causes.
• Collaborate with management to review and approve Cell or COE events and deviations.
• Track deviations, events, and key process parameters; report to management on trending and status as requested.
• Recommend corrective actions for any identified trends.
• Act as subject‑matter expert to customers, providing guidance on deviations, investigations, and product quality issues.
• Identify and implement process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
• Implement process improvements within the change control system.
• Recognize potential compliance issues and opportunities for process changes/improvement.
• Partner with all Cells and COEs to implement process improvements.
• Work with management to allocate resources for change control, equipment startup, and technical training.
• Assure regulatory compliance and technical feasibility of proposed changes.
• Develop business cases for projects and present them to site leadership for approval.
• Initiate and execute change controls for projects.
• Assist with equipment startup and technical training as required.
• Serve as project manager for the change process and coordinate between Cells and COEs to ensure timely implementation.
• Share best practices between production sites.
• Provide technical support concerning the change control system.
• Provide technical support for process and cleaning validation maintenance and verification.
• Assist with cleaning cycle optimization and revalidation efforts.
• Serve as subject‑matter expert during internal and external regulatory audits, including FDA and EMEA.
• Maintain databases of production information, extracting data from SCADA and Delta‑V servers for monitoring and troubleshooting.
• Work with Automation and Information Management to improve process data collection and analysis.
• Coordinate data collection and trend analysis as requested by QA and Regulatory Affairs, including the annual Statistical Quality Control Database (SQC) and Annual Product Review (APR).
• Demonstrate expertise in cGMPs, FDA regulations, cell banking, formulations, cell culture, chromatographic purification, ultrafiltration, microfiltration, diafiltration, viral inactivation, filter integrity testing, CIP/SIP systems, pharmaceutical water systems and utilities.
• Provide documentation support for SOP/Batch Record revisions, identify necessary changes, and ensure timely revision.
• Review and approve SOP and Batch Record revisions for the Cell or COE.

• B.S. degree in a technical area with 5+ years’ experience in a manufacturing environment, biopharmaceutical or pharmaceutical industry experience, or an equivalent combination of education and experience or relevant military experience.
• Independently performs investigations, process improvements, scheduling, training, and document revisions.
• Identifies issues and implements…