Project Reliability Engineer

Role Summary:

• Our client based in Co. Dublin is seeking an experienced and motivated Project Reliability Engineer to join their Fill Finish manufacturing site on a 12-month contract basis.
• This role will be pivotal in driving equipment reliability and supporting the existing syringe line isolator.

Core Duties and Responsibilities:

• Implementing reliability actions:
  • Equipment modifications
  • Vendor interactions
  • Process improvements – SOP changes, etc.
  • Change control management
• New product introductions:
  • Supporting new product introductions from make a batch thru to PPQ
  • Point of contact for the engineering support team to the NPI team
  • Provide upfront input into NPI
  • On the floor execution support during PPQ
• Provide technical expertise and troubleshooting support for Fill and Finish equipment issues
• Work closely with production, quality, and engineering teams
• Support qualification and validation activities for equipment modifications and improvements
• Lead reliability improvement initiatives for Fill and Finish equipment
• Develop and implement predictive and preventive strategies to maximize equipment uptime and Overall Equipment Effectiveness
• Conduct root cause analysis (RCA) and failure mode effects analysis (FMEA) for equipment failures and reliability issues
• Monitor and analyse equipment performance metrics
• Collect, analyse, and report on reliability metrics and KPIs
• Identify trends and patterns in performance data to drive proactive interventions
• Develop business cases for upgrades or replacements based on reliability data
• Ensure all reliability activities comply with regulatory requirements
• Maintain accurate documentation of reliability studies, analyses, and improvement initiatives

Minimum Qualifications and Experience:

• Bachelor’s Degree in Engineering (Mechanical, Chemical, Industrial, or related field)
• Minimum 3 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
• Understanding of GMP requirements and pharmaceutical manufacturing standards
• Excellent analytical and problem-solving skills
• Effective communication skills with ability to influence cross-functional teams

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