Principal MES Engineer (Rockwell PharmaSuite)

Location: Charlotte or Holly Springs, North Carolina, United States. The role starts with a mix of remote and onsite work, including work at the General Planner's office and construction site, and transitions to full-time onsite work in Holly Springs after the facility is built and equipment is delivered. Travel of up to 30% is expected during the project phase.

Salary: $95,200–$176,800 per year, plus a possible discretionary annual bonus.

Company

hirify.global, a member of the Roche Group, develops medicines and biotechnology solutions for serious and life-threatening diseases.

What you will do

• Lead Rockwell PharmaSuite recipe authoring for drug product manufacturing processes in a GMP environment.
• Participate in basic design, detailed design, facility startup, and core MES system configuration.
• Support MES architecture and integrations with SAP, LIMS, automation, and data historian systems.
• Lead MES activities for equipment and software FAT, SAT, field testing, commissioning, and startup.
• Provide operational support by assessing discrepancies, troubleshooting automation issues, and supporting plant operations on the manufacturing floor.
• Maintain system administration, user access, performance monitoring, validated-state controls, and 24/7 on-call readiness.

Requirements

• Bachelor's or master's degree in engineering, chemical engineering, mechanical engineering, electrical engineering, or computer science.
• At least 8 years of applicable MES experience, preferably with substantial drug product experience.
• Deep experience with Rockwell PharmaSuite implementation and recipe authoring.
• Experience with MES lifecycle support, patch management, system upgrades, configuration control, SQL, middleware, and server troubleshooting.
• Expert knowledge of GMP, 21 CFR Part 11, GAMP 5, and data integrity principles.
• Ability to produce and review URS, PRS, FS, and DS documentation.

Nice to have

• Experience executing a Greenfield biopharmaceutical manufacturing project and transitioning into operational lifecycle support.
• Experience with drug product manufacturing, facility design, construction, or startup.

Culture & Benefits

• Regular employment with benefits eligibility.
• Participation in a 24/7 on-call environment after facility go-live.
• Relocation benefits are not available for this position.
• hirify.global is an equal opportunity employer.