Associate Manufacturing Process Specialist

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Supply Chain Manufacturing

Manufacturing Pharmaceutical Process Operations

Professional

Wilson, North Carolina, United States of America

The Associate Manufacturing Process Specialist is responsible for performing technical expert supporting the manufacturing of biological products both on the site and across the network.

Provides technical expertise to ensure that atypical events and non‑conformance investigations relating to production and the testing of materials and products are completed in compliance with all applicable procedures and regulations. Monitors and trends key process parameters, troubleshoots manufacturing problems as required, and provides primary technical support. Identifies and implements process improvements locally and across the network. Supports capital projects, site‑wide initiatives or other projects as needed in the capacity of a project manager or subject‑matter expert.

Conducts technical and validation studies.

• Provides primary (on‑floor) production support.
• Provides technical support for the investigation and resolution of deviations and atypical events.
• Partners with the primary investigator to ensure consistent quality standards are maintained.
• Provides technical expertise to help identify true root cause of investigations and assess product quality impact. Approves investigations as management technical representative when needed.
• Recommends, owns and implements corrective/preventive measures aimed at improving compliance and reducing repeat occurrences. Follows up to determine if corrective actions adequately addressed root cause.
• Collaborates with management to review and approve Cell or COE events and deviations.
• Tracks deviations, events and key process parameters and provides reports to management on trending and status as requested. Recommends corrective actions for any identified trends.
• Acts as subject‑matter expert (SME) to customers, providing guidance on deviations, investigations and issues pertaining to product quality.
• Identifies and implements process improvements related to safety, environmental, quality, compliance, productivity, yield and cost. Implements improvements within the change‑control system.
• Recognizes and acts on potential compliance issues and opportunities for process changes/improvement.
• Partners with all Cells and COEs to implement process improvements. Works with management to allocate group resources to assist with change‑control, equipment startup and technical training. Assures regulatory compliance and technical feasibility of proposed changes.
• Develops business cases for projects and presents to site leadership for approval. Initiates and executes change controls for projects. Assists with equipment startup and technical training as required.
• Serves as project manager for the change process and provides coordination between Cells and COEs to ensure timely and compliant implementation of process improvements.
• Shares best practices between production sites.
• Provides technical support concerning the change‑control system.
• Provides technical support for process and cleaning validation maintenance and verification. Assists with cleaning cycle optimization and revalidation efforts.
• Serves as SME during internal and external regulatory audits (including FDA, EMEA).
• Maintains various databases of production information:
• Extracts process data from SCADA and Delta‑V servers for use in databases maintained by technical operations.
• Uses databases to monitor process performance and proactively troubleshoot operations. Works with Automation and Information Management to improve effectiveness of process data collection and analysis.
• Coordinates data collection and trend analysis as requested by QA and Regulatory Affairs, including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).
• Demonstrates expertise in cGMPs, FDA regulations, cell banking,…