Senior Engineer Facilities

Reporting to the Director Facilities & Engineering, the Senior Engineer Facilities is responsible leading the equipment reliability program, championing continuous improvement, running capital projects (up to and above $250k), and being the site authority on facility and utility systems. The role combines the benefit of small site (agile and broad responsibilities) with the structure, knowledge, and resources of a leading global pharmaceutical company.

This is a senior level role where the engineer can assess current state issues, develop plans, initiate projects, and drive execution to eliminate future issues/failures. This position is 5 days a week onsite and may require after hours or weekend support as required.

Job Responsibilities

Site Subject matter Expert (SME) on one of:

• Critical Utilities (Purified Water Systems, Lab DI, Nitrogen, Specialty gases, and Calibration Business Process)
• GMP Infrastructure (HVAC, Chilled and Hot Water Systems, HEPA certs & Air Balancing, ISO8 infrastructure, and SAP Work Order Business Process)
• SHE Equipment (Waste Water Systems, Fire Protection Systems, Emissions Systems, Electrical distribution, and Spare Parts Business Process)

Understand site structure and processes outside of the facilities department to be advisors for decision makers (comprehensive view).

Own and accountable for the success of either the Critical Utilities or the GMP Infrastructure equipment.

• Drive appropriate actions to correct and improve issues/failures as they occur
• Develop and update maintenance plans and SOPs to improve reliability of equipment using Reliability Centered Maintenance (RCM) principles and/or Total Productive Maintenance (TPM).
• Utilize site reliability programs including vibration monitoring, lubrication, IR, and water chemistry to predict potential equipment issues o Identify, develop, and execute multiple small capital projects in addition to BAU projects to improve their equipment and overall site o Author and execute facilities GMP and Non GMP systems commissioning and qualifications
• Responsible for investigating deviations and completing other quality records such as change controls, deviations and CAPAs related to their equipment to eliminate future issues o Review and respond to excursions in environmental and utility sampling for their equipment o Coach and train facilities technicians on new systems operation and maintenance
• Experience with automation systems and HMIs including BMS and Factory Talk systems in addition to advanced knowledge of SAP
• Perform and have expertise around regulations for alarm management and local regulatory agencies (air quality and sanitary sewer districts) depending on equipment ownership
• Responsible for Facilities shutdown planning and execution
• Responsible for facilities drawing management program Use lean methodologies and tools including Level 0s, 5S, Practical Problem Solving, and Standard Work to improve processes and equipment reliability
• Facilities subject matter expert on Safety, Health and Environmental (SHE) policies and adheres to all SHE policies o Coordinate and supervise outside vendors, contractors and consultants to ensure that their work is performed safely, is of a high standard, and properly documented o Responsible for facilities Lockout-tagout program
• Lead the development and implementation of operational improvements to plant systems to improve sustainability, reduce carbon footprint, and optimize performance
• Collaborate and support other engineer and department team members by teaching and sharing technical knowledge with them to help them upskill and grow Safety, Health and Environment Promoting an environment of no hurt, harm, or alarm
• Maintains a safe work environment and performs work in accordance with site Environment, Health and Safety (SHE) policies and procedures.
• Work in a manner that promotes the safety and well-being of self, others and the environment
• Contribute to improving SHE performance, proactively use SHE Reporting System to identify SHE hazards, and take appropriate actions
• Immediately reports potential unsafe conditions to management. GMP / Compliance and Ethical Conduct Ensuring compliance of self and others to internal and external regulations
• Comply with all systems, processes, and procedures in line with statutory/ legislative / quality requirements
• Ensure compliance with AZ Corporate Policies an directives, site Standard Operating Procedures, regulatory requirements, and industry best practices (cGMPs, GAMP, ITIL, PMI).
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role.
• Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time.
• Report potential issues of non-compliance. Delivery / Supply
• Ensuring customer service is always considered. Cost
• Promoting a cost-conscious environment to enable effective cost management.
• GMP / Compliance and Ethical Conduct Ensuring…