Lead Maintenance Specialist

Scorpion Therapeutics; Morrisville (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Scorpion Therapeutics in Morrisville, NC seeks a Maintenance Specialist to ensure GMP-compliant operation and lifecycle management of manufacturing equipment, facilities, and utilities in a biopharma setting.

You will oversee asset turnover, participate in commissioning and qualification, optimize preventive maintenance, coordinate across HVAC and labs, manage vendors, and support audits while driving reliability improvements.

Qualifications

• B.S. in Engineering or related field with 8+ years of relevant experience, or H.S. diploma with 12+ years in pharma facilities maintenance.
• Experience with CMMS platforms such as Maximo or SAP PM.
• Knowledge of GMP, FDA 21 CFR Parts 210, 211, Part 11, and validation processes.

Responsibilities

• Oversee asset turnover and lifecycle management of manufacturing equipment and facilities.
• Participate in commissioning, qualification, and startup activities.
• Optimize preventive and predictive maintenance programs.
• Coordinate maintenance across HVAC, utilities, process, and laboratory equipment.
• Manage vendor activities and ensure documentation compliance.
• Support regulatory audits and investigations.
• Drive continuous improvement and reliability initiatives.

Skills

Maintenance knowledge

Reliability

Project management

Troubleshooting

Stakeholder collaboration

Documentation

Education

B.S. in Engineering or related field

High school diploma + 12+ years pharmaFacilities maintenance

Tools

Maximo

SAP PM

Job description

Role: Maintenance Specialist ensuring GMP-compliant operation and lifecycle management of manufacturing equipment, facilities, and utilities in a biopharma manufacturing setting.

Responsibilities

• oversee asset turnover
• participate in commissioning, qualification, and startup
• optimize preventive and predictive maintenance programs
• coordinate maintenance across HVAC, utilities, process, and laboratory equipment
• manage vendor activities and ensure documentation compliance
• support regulatory audits and investigations
• drive continuous improvement and reliability initiatives

Requirements

• B.S. in Engineering or related field with 8+ years of relevant experience, or high school diploma with 12+ years in pharmaceutical facilities maintenance
• experience with CMMS platforms (e.g., Maximo, SAP PM)
• knowledge of GMP, FDA 21 CFR Parts 210, 211, Part 11, and validation processes

Preferred

• familiarity with CQV, ISPE guidelines, reliability-centered maintenance, and predictive maintenance tech

Skills

• strong maintenance and reliability knowledge, project management, troubleshooting, stakeholder collaboration, and documentation skills

HighValue

• GMP pharmaceutical manufacturing, utilities and facilities management, compliance with regulatory standards, support for audits and validations, and work in a GMP environment

Location/work setup and travel details are not specified.