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Kedrion Biopharma is recruiting a Reliability Engineer to join the Technical Engineering team at our Elstree site in a fully on‑site role. This is a key position supporting the development and embedding of a sustainable reliability programme across regulated manufacturing operations. With a strong mechanical reliability focus, the role is ideal for an engineer who enjoys hands‑on asset performance improvement, structured problem solving and working closely with cross‑functional teams to reduce downtime, manage risk and continuously improve equipment effectiveness while maintaining full cGMP and GEP compliance.
You will be part of an organisation that invests in its people and provides the opportunity to make a meaningful impact in a pharmaceutical manufacturing environment.
What you'll do
Support the structured development and implementation of the site reliability programme in line with cGMP and GEP requirements, engaging Engineering, Production and Quality teams in the journey towards world‑class asset management
Identify, assess and manage asset reliability risks that could adversely impact plant performance, safety, compliance or business operations
Provide hands‑on mechanical engineering support across a wide range of plant and process equipment, including pumps, motors, centrifuges, vessels and associated systems
Lead and support fault investigation activities using structured root cause analysis techniques to eliminate repetitive failures and improve equipment performance
Analyse asset performance using recognised reliability metrics, including asset utilisation, MTBF, MTTR, OEE, TEEP and remaining useful life
Define, review and improve asset maintenance strategies, including spare parts strategies, to ensure effective preventive and predictive maintenance activities
Apply and promote modern maintenance and reliability methodologies, providing technical coaching and training to engineering, operations and other stakeholders
Use recognised reliability tools and risk assessment techniques such as PHA, FMEA, RCA, RCM, criticality analysis, SFMEA and TPM to prioritise actions and drive sustainable improvement
Develop engineering solutions that address capacity, quality, cost and regulatory compliance issues linked to equipment reliability
Work closely with Capital Projects during the design, installation and modification of assets to ensure reliability and maintainability are built in from the outset
Participate in factory and site acceptance testing and final equipment check‑out to ensure adherence to functional and reliability requirements
Define, monitor and review Asset Maintenance Plans with subject matter experts to ensure value‑adding maintenance tasks and appropriate predictive technologies are deployed
Ensure appropriate support contracts are in place for critical equipment, balancing operational risk and cost
Develop and maintain reliability standards, engineering procedures and standard operating procedures in collaboration with Process Engineering and other functions
Support value‑based decision making for repair, replacement, redesign and make‑or‑buy activities
Qualifications and need-to-know
Degree in an engineering‑related discipline, with a mechanical engineering background
Experience or awareness of reliability and risk analysis tools, including RCA, FMEA and equipment criticality analysis
Ability to create, review and update BEMP documentation and produce clear, accurate technical reports
Experience completing equipment criticality assessments within a manufacturing environment
Understanding of Computerised Maintenance Management Systems (CMMS)
Working knowledge of health and safety legislation, policies and procedures
Knowledge of quality management systems within a pharmaceutical GMP environment
Knowledge of predictive maintenance techniques and their practical application
Ability to communicate complex technical information clearly to both technical and non‑technical stakeholders
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