Sr. Principal Engineer, Equipment Preparation Lead

Role: Senior Principal Engineer, Equipment Preparation Lead, within Johnson & Johnson's Innovative Medicine division, focusing on process engineering for cGMP drug manufacturing facilities. Responsibilities: lead end-to-end design, development, and commissioning of equipment preparation systems (autoclaves, parts washers, filter testing, COP/SOP); review vendor capabilities, oversee FAT, SAT, C&Q activities; resolve technical issues, ensure compliance with cGMP, EHS, and regulatory standards (EU, FDA); collaborate across manufacturing, quality, facilities, and external partners; develop specifications, technical documentation, and project plans; drive process optimization and technical excellence. Requirements: Bachelor's in engineering (MS or MBA preferred), minimum 10 years in process engineering or capital project execution for aseptic equipment, strong stakeholder partnership experience, expertise in regulatory standards and equipment validation, and project management skills. Preferred: leadership in large-scale GMP facility startups ($100-500M), extensive experience with aseptic processing equipment and biotherapeutic environments, and green/brownfield project management. High-Value: focus on aseptic manufacturing, equipment validation, regulatory compliance (EU Annex 1, FDA), and process optimization in biopharma drug product facilities. Work Setup: full-time onsite in Wilson, North Carolina, with >75% travel during project phases.