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. Key Responsibilities 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. Qualifications 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 resolutions; assesses data; prepares and reviews documentation independently. Reviews and approves documents and investigations under rigorous data analysis, with support using complex data mining techniques. Working knowledge of cGMPs in a biopharmaceutical or pharmaceutical manufacturing environment is preferred. Ability to apply basic project management skills to complete assigned projects effectively, consistently, and on challenging schedules. Influencing, partnering, collaboration, analytical, good oral and written presentation skills required; demonstrated ability to work across organizational boundaries. Knowledge of FDA/EMEA regulatory requirements related to biologics and/or pharmaceuticals is preferred. Other Requirements Mobile with ability to transport independently between various sites/locations as dictated by essential functions. Frequently required to communicate with coworkers. Perform gowning procedures in applicable areas. Ability to stand, walk, sit, climb, bend, stoop, or reach with hands and arms for extended periods. Ability to lift, push or pull up to 40 lbs. Ability to interpret and carry out a variety of technical instructions in written, oral, diagram, mathematical, or schedule form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Must be available for daytime, off‑shift, on‑call, or rotational support as required. Designated for off‑hours (night) shift during the commercial phase. Additional duties may be assigned as necessary. Equal Employment Opportunity Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us at Internal employees contact AskGS to be directed to your accommodation resource. #J-18808-Ljbffr