Major Activities

• 5 -7  years minimum working in a highly regulated environment, planning, execution and supervision of  Facility, Process or Maintenance engineering.
• Min 3 years working in a Biopharma Cleanroom facility.
• Supporting Site Capital Projects from a Utility and Facility Installation, Commissioning perspective.
• Oversee service contractor activities for PPM and calibration activities, including managing EHS permitting requirements in line with site procedures.
• Assist with the continuous development and implementation of the internal and external PPM schedule, and ensuring adherence to it.
• Ability to develop maintenance procedures, plan, schedule and execute PPM and reactive maintenance as required. 
• Maintain all current statutory, regulatory and company safety and quality standards.
• Assist with the implementation, maintenance and measurement of a framework for compliance and ongoing improvement in quality performance and right first time culture within the facilities and engineering area. This will be in accordance with statutory, regulatory and company standards, procedures and systems regarding relevant cGMP, Quality Systems and Health and Safety in the workplace.
• Ensure the availability and reliability of building utilities, services and manufacturing equipment for the operational areas, in order that they can achieve the plans to satisfy customer requirements. 
• Develop and manage strong relationships across teams to remove barriers and time lags. 
• Assist with the identification and implementation of technology based and working practice solutions designed to reduce the overall cost per unit measures.  
• Assist with the development and maintenance of the engineering budget and and critical spares stock list.
• Knowledge of Calibration methodologies and planning is desirable.
• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
  • Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner.
  • Responsible for ensuring that any assigned GMP documentation assigned,e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state.

• Improving Key Performance Indicator’s for building utilities services; equipment availability and performance; safe and quality compliant facility operations.
• Development of an asset care strategy and growing profitability through reducing the cost per unit measures.  
• The individual must have a track record in working in a cleanroom environment.

• Comprehensive practical and theoretical background on a wide range of industrial plant and cleanroom services and utility equipment.
• Proven experience in implementing engineering techniques - typically compressed air, Oxygen, HVAC and Utility systems applied to both general industrial and clean room standards.
• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations.
• Leadership - exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
• Cost Consciousness - works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources.
• Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; 
• Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
• Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
• Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and consistency.
• Innovation - displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
• Oral Communication - speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
• Written Communication - writes clearly and informatively;; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.