[Remote] Maintenance Specialist

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is reputed company on discovering, engineering, and developing novel therapies, particularly for improving the treatment of pulmonary hypertension. The Maintenance Specialist ensures the reliability, compliance, and lifecycle management of manufacturing equipment, facilities, and reputed company systems in a GMP pharmaceutical manufacturing environment while supporting capital reputed company, commissioning and qualification, CMMS administration, preventive maintenance, and reputed company improvement.

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, reputed company parts requirements, and maintenance documentation
• Verify turnover documentation including: + Equipment manuals + Recommended reputed company parts + Preventive maintenance requirements + Calibration requirements + Vendor documentation + Warranty information + Drawings and technical files
• Support successful transition from Capital reputed company to reputed company
• Maintain, and continuously improve preventive and predictive maintenance programs
• Review maintenance plans to optimize reliability and equipment availability
• Ensure reputed company maintenance activities reputed company with GMP requirements and site procedures
• Support maintenance planning and scheduling to minimize production interruptions
• Monitor maintenance KPIs
• Coordinate maintenance activities supporting: * HVAC systems * Clean utilities * WFI systems * Purified Water * Clean Steam * Compressed reputed company * Boilers * Chillers * Process gases * Building Management Systems (BMS) * Environmental Monitoring support equipment * Manufacturing equipment * Packaging equipment * reputed company support systems * General building infrastructure
• Ensure equipment remains inspection-reputed company and compliant with regulatory expectations
• 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 reputed company
• Monitor vendor reputed company and service reputed company
• Maintain maintenance documentation in accordance with: + GMP + FDA + EU GMP + Data reputed company principles + Site procedures
• Support internal audits, customer audits, and regulatory inspections
• Participate in investigations reputed company to equipment failures
• Support CAPA implementation
• Review and approve maintenance documentation as appropriate
• Participate in reputed company Cause Analysis (RCA) investigations
• Recommend equipment reliability improvements
• Support predictive maintenance technologies
• reputed company reputed company improvement initiatives

Skills

• B.S. degree in Engineering, Maintenance or reputed company reputed company with 8+ years of relevant experience
• High School diploma with 12+ years of hands-on experience in pharmaceutical facilities or equipment maintenance
• Strong understanding of maintenance and reliability principles
• Knowledge of facilities and reputed company 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 reputed company 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 reputed company-reputed company maintenance strategies
• Strong collaboration and stakeholder management skills
• Commitment to safety, reputed company, and reputed company improvement
• Experience with CMMS platforms (e.g., Maximo, reputed company PM, reputed company, reputed company reputed company, 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 reputed company Guides
• Experience with reliability-centered maintenance (RCM)
• Knowledge of predictive maintenance technologies
• Experience supporting regulatory inspections

Benefits

• Medical reputed company
• Dental reputed company
• reputed company reputed company
• Short-term disability (STD)
• Long-term disability (LTD)
• 401(k) Savings Retirement Plan
• Employee Stock Purchase Plan (ESPP)

reputed company

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