Project Reliability Engineer

Prochem Engineering; Leinster; On-site; EUR 65,000 - 80,000; Full time

Job summary

Prochem Engineering's client in Co. Dublin is seeking an experienced Project Reliability Engineer for a 12-month contract on a Fill Finish manufacturing site. The role focuses on driving equipment reliability and supporting the syringe line isolator.

You will implement reliability actions, lead RCA/FMEA activities, support NPI and PPQ processes, and collaborate with production, quality, and engineering teams to maximize uptime and OEE while maintaining GMP compliance.

Qualifications

• Bachelor's Degree in Engineering (Mechanical, Chemical, Industrial, or related field).
• Minimum 3 years of reliability engineering experience, preferably in pharmaceutical or sterile manufacturing.
• Experience with Fill and Finish operations or aseptic processing is highly desirable.
• GMP knowledge and pharmaceutical manufacturing standards understanding.
• Excellent analytical and problem-solving skills.
• Effective communication to influence cross-functional teams.

Responsibilities

• Implement reliability actions including equipment modifications and change control management.
• Support New Product Introductions from make a batch to PPQ.
• Provide upfront input into NPI and on-the-floor execution support during PPQ.
• Offer technical expertise and troubleshooting for Fill and Finish equipment.
• Collaborate with production, quality, and engineering teams.
• Support qualification and validation activities for equipment modifications.
• Lead reliability improvement initiatives for Fill and Finish equipment.
• Develop and implement predictive and preventive strategies to maximize uptime and OEE.
• Conduct RCA and FMEA for equipment failures and reliability issues.
• Monitor, analyze, and report reliability metrics and KPIs.
• Identify trends to drive proactive interventions.
• Develop business cases for upgrades or replacements based on data.
• Ensure reliability activities comply with regulatory requirements.
• Maintain documentation of reliability studies and initiatives.

Skills

Reliability engineering

Analytical skills

Problem-solving

Cross-functional collaboration

Education

Bachelor's Degree in Engineering (Mechanical, Chemical, Industrial, or related field)

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.