Kedrion Biopharma is recruiting for a Reliability Engineer to join the Production Engineering department and support the development and implementation of a sustainable reliability program to reduce reliability risks. This role will operate closely with Production, Projects, Facilities and Engineering teams to ensure optimised efficiency of equipment and assets and ensure effective reliability processes are developed.
Reporting into the Production Engineering Reliability Manager, the successful candidate will identify and implement projects using robust root cause analysis to reduce those losses or lower costs.
This exciting position will offer the successful candidate the opportunity to help build a modern, positive, and strong image for the company as it grows, solidifying its presence as rank #5 leader of Plasma Derived Medicinal Products (PDMPs) for patients and customers worldwide.
Our site is not easily accessible by public transport so please take this into consideration when applying as this role is fully on-site.
Duties & Responsibilities:
Support the continued development of the reliability program for Kedrion Elstree. Implement the program in a structured approach in-line with cGMP and GEP whilst bringing the Engineering, Production and Quality teams along in the journey to World Class asset management.
Identify and manage asset reliability risks that could adversely affect plant or business operations.
Guide efforts to ensure reliability and maintainability of equipment, processes, utilities, facilities, controls, and safety/security systems.
Provide hands-on technical engineering support, training, and coach others in relevant aspects of equipment performance.
Be involved in the design and installation stages of projects for new assets and modification of existing assets to ensure ongoing reliability.
Perform analyses of assets including:
Asset Utilisation / MTBF (Mean Time Between Failures) / MTTR (Mean Time To Recover)
OEE (Overall Equipment Effectiveness) / TEEP (Total Effective Equipment Performance)
Remaining useful life
Other parameters that define operating condition, reliability, and costs of assets
Spare Parts strategy
Provide training and coaching on the following:
Diagnostic troubleshooting
Predictive Technologies
Modern maintenance strategies
Have a working knowledge of Statistical Process Control & Six Sigma (6σ) Methodology.
Be familiar with implementing typical reliability risk assessment tools including:
PHA - Preliminary hazards analysis
FMEA - Failure modes and effects analysis
RCA – Root Cause Analysis (including FTA - Fault tree analysis & ETA - Event tree analysis)
RCM – Reliability Centred Maintenance
CA - Criticality analysis
SFMEA - Simplified failure modes and effects analysis
TPM – Total Productive / Predictive Maintenance
Ensure value-added preventive maintenance tasks.
Correctly deploy predictive and other non-destructive testing methodologies designed to identify and isolate inherent reliability problems.
Develop reliability standards, design standards, engineering procedures and standard operating procedures in conjunction with Process Engineering.
Work with Capital Projects to ensure the reliability and maintainability of new and modified installations. Participate in the final check out of new installations, including factory and site acceptance testing that will assure adherence to functional specifications.
Apply value analysis to repair/replace, repair/redesign, and make/buy decisions.
Skills & experience to help you within the role –
We're looking for someone with technical knowledge, attention to detail, integrity and self-motivation. Collaborative, communicative and a flexible team player. You must be organised with a close attention to detail, able to maintain accurate and robust records.
Essential:
Applications from candidates with a degree in an engineering related discipline.
Awareness of RCA / FMEA / Criticality analysis processes.
Excellent communicator with the ability to analyse and impart knowledge.
Ability to Create, Review, and Update BEMP’s.
Ability to create and review Technical Reports.
Ability to complete equipment criticality assessments.
Desirable:
Understanding of CMMS (Computerised Maintenance Management Systems).
Working knowledge and awareness of Health and Safety Legislation, policies and procedures.
Knowledge of Quality Management Systems within a Pharmaceutical GMP Environment.
Knowledge of Predictive Maintenance techniques and how to apply them in the field.
Ability to develop and deliver technical training to technical and non-technical staff.
Ability to understand complex information and relay it to staff in an appropriate way.
In return we offer -
We're looking for highly motivated and experienced people to drive the business forward. In return you'll be supported in developing your skills with ongoing training and career opportunities.
Competitive salary
Bonus
25 days holiday
Pension
Life insurance
On-site parking
Employee assistance programme
My Healthy Advantage phone app
Virtual GP
Cycle to work scheme
Subsidised canteen
Kedrion Biopharma is a biopharmaceutical company headquartered in Italy, which collects and fractionates blood plasma to produce and distribute worldwide plasma-derived therapies for use in treating and preventing serious diseases, disorders, and conditions.
Please apply today for immediate consideration.
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