Reliability Engineer

Role Summary:

• We are seeking a skilled and motivated Reliability Engineer to join our client’s Fill and Finish manufacturing operations on a 12-month contract.
• This role will be instrumental in driving equipment reliability, reducing unplanned downtime, and optimizing asset performance in their critical sterile manufacturing environment.

Core Duties and Responsibilities:

Equipment Reliability & Performance

• Lead reliability improvement initiatives for Fill and Finish equipment including filling lines, lyophilizers, ancillary equipment
• Develop and implement predictive and preventive maintenance strategies to maximize equipment uptime and OEE (Overall Equipment Effectiveness)
• Conduct root cause analysis (RCA) and failure mode effects analysis (FMEA) for equipment failures and chronic reliability issues
• Monitor and analyse equipment performance metrics including MTBF (Mean Time Between Failures), MTTR (Mean Time To Repair), and availability

Maintenance Strategy & Optimization

• Review and optimize preventive maintenance schedules based on equipment criticality and failure history
• Support the transition from reactive to predictive maintenance approaches
• Collaborate with maintenance teams to develop and update standard operating procedures and work instructions
• Identify opportunities for condition-based monitoring and implement appropriate technologies

Technical Support & Problem Solving

• Provide technical expertise and troubleshooting support for Fill and Finish equipment issues
• Work closely with production, quality, and engineering teams to resolve equipment-related production constraints
• Support qualification and validation activities for equipment modifications and improvements
• Participate in change control processes ensuring GMP compliance

Data Analysis & Continuous Improvement

• Collect, analyze, and report on reliability metrics and KPIs
• Identify trends and patterns in equipment performance data to drive proactive interventions
• Lead or participate in continuous improvement projects using Lean and Six Sigma methodologies
• Develop business cases for equipment upgrades or replacements based on reliability data

Compliance & Documentation

• Ensure all reliability activities comply with cGMP, FDA, EMA, and other regulatory requirements
• Maintain accurate documentation of reliability studies, analyses, and improvement initiatives
• Support internal and external audits related to equipment reliability and maintenance

Minimum Qualifications and Experience:

• Bachelor’s Degree in Engineering (Mechanical, Electrical, Industrial, or related field)
• Minimum 3-5 years of experience in reliability engineering, preferably in pharmaceutical or sterile manufacturing environments
• Demonstrated experience with Fill and Finish operations or aseptic processing is highly desirable
• Strong knowledge of reliability engineering principles, methodologies, and tools (RCA, FMEA, RCM)
• Proficiency in data analysis and statistical methods
• Experience with CMMS (Computerized Maintenance Management Systems)
• Understanding of GMP requirements and pharmaceutical manufacturing standards
• Familiarity with predictive maintenance technologies (vibration analysis, thermography, oil analysis)
• Excellent analytical and problem-solving skills
• Strong project management capabilities
• Effective communication skills with ability to influence cross-functional teams
• Proficiency in Microsoft Office Suite; experience with data visualization tools is a plus
• Lean Six Sigma certification (Green Belt or higher) is advantageous

Please note, we do not require agency assistance with this role.