Associate Manufacturing Process Specialist (Biopharmaceutical Manufacturing)

Location: Onsite in Wilson, North Carolina, United States; daytime work during the project phase, with routine off-shift and rotational on-call support potentially required. During the commercial phase, the role will work an off-hours night shift.

Company

Johnson & Johnson MedTech develops healthcare and biopharmaceutical solutions designed to improve disease prevention, treatment, and patient outcomes.

What you will do

• Provide on-floor technical support for biological product manufacturing, technical issues, process improvements, and business reliability.
• Support investigations of deviations and atypical events, identify root causes, assess product-quality impact, and implement corrective and preventive actions.
• Monitor and trend key process parameters, extract data from SCADA and DeltaV servers, and prepare reports for management, QA, and Regulatory Affairs.
• Identify and implement improvements related to safety, environmental performance, quality, compliance, productivity, yield, and cost.
• Coordinate change controls, equipment startup, technical training, validation studies, and projects as a project manager or subject matter expert.
• Support regulatory audits, SOP and batch-record revisions, process and cleaning validation, and knowledge sharing across production sites.

Requirements

• Bachelor’s degree and 0–2 years of experience in manufacturing, biopharmaceuticals, pharmaceuticals, or equivalent education and experience.
• Experience in at least one bioprocess area, such as protein purification, ultrafiltration, virus filtration, or media and buffer preparation.
• Working knowledge of cGMP requirements in a biopharmaceutical or pharmaceutical manufacturing environment.
• Basic project management, analytical, communication, presentation, collaboration, and influencing skills.
• Ability to work effectively across organizational boundaries in a dynamic, multicultural, and matrixed environment.
• Ability to comply with applicable FDA, EPA, OSHA, and other local, state, and federal regulations.

Nice to have

• Experience with cleaning and sterilization validation, autoclaves, and sterilization processes.
• Knowledge of FDA and EMEA regulatory requirements for biologics or pharmaceuticals.
• Experience with process optimization, analytics dashboards, data analysis, gap analysis, or operational excellence.

Culture & Benefits

• Inclusive work environment centered on individual dignity, diversity, and respect.
• Work in a regulated biopharmaceutical manufacturing environment with cross-functional and network-wide collaboration.
• Responsibilities may include training new staff and supporting site-wide initiatives.
• High ethical standards and compliance with company policies and the Johnson & Johnson Credo.