Associate Manufacturing Process Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

The Associate Manufacturing Process Specialist supports the manufacturing of biological products on the site and across the network, providing technical expertise, troubleshooting and process improvement.

• Provide technical expertise for atypical event and non-conformance investigations for production and testing of materials and products.
• Monitor and trend key process parameters.
• Troubleshoot manufacturing problems and provide primary technical support.
• Identify and implement process improvements locally and across the network.
• Support capital projects, site‑wide initiatives and other projects as project manager or subject matter expert.
• Conduct technical and validation studies and provide on‑floor production support.
• Investigate and resolve deviations and atypical events, partnering with primary investigators to maintain quality standards.
• Recommend, own and implement corrective/preventive actions to improve compliance.
• Track deviations, events and key process parameters, and report trends to management.
• Act as subject matter expert to customers and regulatory audits, including FDA and EMEA.
• Implement process improvements within the change control system.
• Manage database of production information, extract process data, and support trend analysis.
• Assist with equipment startup, technical training, and cleaning validation.
• Maintain documentation support for SOP/Batch Record revisions.

• B.S. degree in a technical area with 0–3 years of experience in a manufacturing environment.
• Experience in biopharmaceutical or pharmaceutical industry, or equivalent education and experience.
• Understanding of cGMPs, FDA regulations, and manufacturing processes such as cell culture, chromatography, filtration and water systems.
• Basic project management skills and ability to meet schedules.
• Strong influencing, partnering, analytical, oral and written communication skills.
• Knowledge of FDA/EMEA regulatory requirements preferred.

Physical ability to transport between sites, communicate with coworkers, perform gowning procedures, lift up to 40lbs, stand, walk, sit, climb, bend, and reach for extended periods. Availability for daytime, off‑shift and on‑call support as required.

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.