Equipment SME

Summary:
The Equipment SME is responsible for establishing and maintaining the safe reliable operation and qualified state of the equipment and business processes across Materials Management (MM) and Supply Chain (SC). The successful candidate will operate across both large (LM) and small molecule (SM) teams acting as a joint engineer. Responsible for ensuring that equipment is in-control, compliant, and capable of meeting customer needs, while also driving continuous improvement effort. Form an integral part of the Temperature Controlled Unit infrastructure, providing support to the TCU Subject matter Expert (SME) and TCU team.

Responsibilities:

• In line with the job outlined above, the following are typically the key tasks that would be expected of the role across MM and SC.
• Know the operational control strategy and how the equipment impacts the key process parameters.
• Know and understand the basis of design for the equipment.
• Educate process team members and operators on equipment requirements.
• Understand potential equipment failure modes and sources.
• Understand equipment capability and process alarm management.
• Understand and lead or participate in Hazard Assessments and Process Hazard Reviews.
• Review and or approve significant changes, maintenance, and other interventions for potential adverse impact on the safety integrity of equipment or process within the scope of the Process Team.
• Take responsibility for the safe design and safe operation of the equipment within the area.
• Be the point of contact for technical expertise of equipment and processes in area of responsibility including clear understanding of equipment flow chart within the process flow document and critical process parameters.
• Monitor the process and optimise equipment performance.
• Lead troubleshooting efforts relating to equipment and operational problems.
• Utilise formal problem-solving techniques, including Root Cause Analysis, to resolve equipment issues and incident investigations.
• Respond to equipment failures, document appropriately and ensure resolution of the event through appropriate actions.
• Measure and understand the main causes of downtime and maintaining cycle time charts.
• Provide an interface with maintenance, utilities and automation when they are not directly represented by the Process Teams.
• Embed and identify new CI opportunities to maximise Operations efficiency.
• Monitoring the qualified state of equipment through the asset life cycle.
• Evaluate all activities for impact on qualified state of equipment and utilise appropriate business process as necessary (change control etc).
• Responsible for system/component classification and maintenance strategy for equipment.
• Own / review deviations that have an impact on engineering infrastructure within the areas.
• Implement corrections, corrective actions, and countermeasures arising from CAPA’s.
• Supporting initial qualification activities (including commissioning activities of new equipment).
• Having a holistic understanding of the process validation and its associated equipment, facilities and computer system validations.
• Assuring equipment is properly maintained.
• Develop scope for capital projects targeted at both short- and longer-term needs.
• Act as user representative for area projects.
• Co-ordinate technical requirements and create / coordinate Change Controls to implement projects across the business areas.
• Understand equipment reliability issues with the objective of improvement.
• Implement AQM across MM and SC.
• At times, the engineer (Electrical/Mechanical/Process) may need to travel offsite to other locations, other pharmaceutical companies, conferences, or off-site training.
• Support the review Temperature mapping strategy, Monthly Temperature Monitoring Report and PRR’s.
• Coordinate with Materials management and Supply Chain area representatives and maintenance to define a spare parts programme for critical assets including TCU’s, downflow booths and HVACs.
• Engineering input into TCU control strategies, temperature mapping and alarm rationalisation.
• Proactively review engineering controls in the area assessing potential for gaps and process improvements.

Qualifications & Experience:

• Degree in Electrical/Process/Mechanical Engineering.
• 7+ years’ experience in the Pharmaceutical and Biopharmaceutical sectors.
• Experience in Temperature controlled Units desirable.
• Experience in equipment qualification and reliability desirable.
• Participation in Technical and Safety reviews.
• Interfacing with client design team/end users.
• Ability to work on own initiative and to challenging schedules.
• Organised and adaptable with a flexible approach to Process/Project Engineering.