Project Reliability Engineer

Prochem Engineering; Leinster; On-site; EUR 60,000 - 80,000; Full time

Job summary

Prochem Engineering's client in Co. Dublin seeks an experienced Project Reliability Engineer to join their Fill Finish manufacturing site on a 12-month contract.

The role focuses on driving equipment reliability for the syringe line isolator and supporting continuous improvement. You will implement reliability actions, lead NPI/PPQ activities, and provide troubleshooting for Fill and Finish equipment issues, while partnering with production, quality and engineering teams to maximise uptime and

Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Industrial or related).
• Minimum 3 years in reliability engineering, preferably in pharma or sterile manufacturing.
• Experience with Fill and Finish operations or aseptic processing is highly desirable.
• Strong GMP knowledge and pharma manufacturing standards.
• Excellent analytical and problem-solving skills; effective cross-functional communication.

Responsibilities

• Implement reliability actions including equipment modifications and change control.
• Lead New Product Introductions (NPI) and PPQ activities with engineering support.
• Provide technical expertise and troubleshooting for Fill and Finish equipment issues.
• Lead reliability improvement initiatives and develop predictive and preventive strategies.
• Perform RCA and FMEA for equipment failures and reliability issues.
• Monitor, analyse and report reliability metrics and KPIs; drive proactive interventions.
• Ensure compliance with regulatory requirements and maintain documentation of studies.

Skills

Analytical skills

Communication skills

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Job description

• 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
• 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.