Maintenance Specialist

Job requirements

• B.S. degree in Engineering, Maintenance or related field with 8+ years of relevant experience.
• High School diploma with 12+ years of hands-on experience in pharmaceutical facilities or equipment maintenance.
• Experience with CMMS platforms (e.g., Maximo, SAP PM, Oracle, Blue Mountain, or similar).
• Knowledge of Commissioning, Qualification, and Validation (CQV).
• Understanding of GMP regulations and pharmaceutical manufacturing.
• Knowledge of FDA 21 CFR Parts 210, 211, and Part 11.
• Familiarity with ISPE Good Practice Guides.
• Experience with reliability-centered maintenance (RCM).
• Knowledge of predictive maintenance technologies.
• Experience supporting regulatory inspections.
• Strong understanding of maintenance and reliability principles.
• Knowledge of facilities and utility systems.
• Excellent organizational and project management skills.
• Ability to prioritize multiple competing activities.
• Strong analytical and troubleshooting skills.
• Excellent written and verbal communication.
• Proficiency with Microsoft Office and CMMS software.
• Ability to interpret engineering drawings, P&IDs, equipment manuals, and technical documentation.
• Strong understanding of equipment lifecycle management.
• Working knowledge of risk-based maintenance strategies.
• Strong collaboration and stakeholder management skills.
• Commitment to safety, quality, and continuous improvement.

Job responsibilities

• Review Engineering Turnover Packages (ETOPs) to ensure completeness and maintenance readiness prior to asset acceptance.
• Participate in project design reviews, FAT/SAT activities, commissioning, qualification, and startup support.
• Coordinate asset induction and enrollment into the CMMS.
• Establish equipment hierarchy, asset records, preventive maintenance strategies, spare parts requirements, and maintenance documentation.
• Verify turnover documentation including: Equipment manuals Recommended spare parts Preventive maintenance requirements Calibration requirements Vendor documentation Warranty information Drawings and technical files
• Equipment manuals
• Recommended spare parts
• Preventive maintenance requirements
• Calibration requirements
• Vendor documentation
• Warranty information
• Drawings and technical files
• Support successful transition from Capital Projects to Operations.
• Maintain, and continuously improve preventive and predictive maintenance programs.
• Review maintenance plans to optimize reliability and equipment availability.
• Ensure all maintenance activities comply with GMP requirements and site procedures.
• Support maintenance planning and scheduling to minimize production interruptions.
• Monitor maintenance KPIs.
• HVAC systems
• Clean utilities
• WFI systems
• Purified Water
• Clean Steam
• Compressed Air
• Boilers
• Chillers
• Process gases

• Environmental Monitoring support equipment
• Manufacturing equipment
• Packaging equipment
• Laboratory support systems
• General building infrastructure
• Coordinate vendor maintenance activities as needed.
• Review vendor service reports for completeness.
• Ensure contractor work complies with site safety and GMP requirements.
• Support contractor qualification and onboarding.
• Monitor vendor performance and service quality.
• Maintain maintenance documentation in accordance with: GMP FDA EU GMP Data Integrity principles Site procedures
• GMP
• FDA
• EU GMP
• Data Integrity principles
• Site procedures
• Support internal audits, customer audits, and regulatory inspections.
• Participate in investigations related to equipment failures.
• Support CAPA implementation.
• Review and approve maintenance documentation as appropriate.
• Participate in Root Cause Analysis (RCA) investigations.
• Recommend equipment reliability improvements.
• Support predictive maintenance technologies.
• Drive continuous improvement initiatives.

Job benefits