Sr. Manager, CTDO Automation

The CTDO Sr. Manager of Automation is responsible for technical leadership and general management responsibilities critical for the efficient functioning of Building Automation Systems for the CAR T manufacturing facility in Summit, NJ to ensure that these systems function properly and remain in compliance. This Sr. Manager will act as subject matter expert for Building Automation and will partner with Engineering to ensure compliance with global and site standards.

Additionally, this position will provide direct supervision of a team consisting of Building Automation technician(s) and external contractors operating at the Summit West site. The team will support investigations related to the Building Automation System, the Environmental monitoring system, HVAC and building controls. This includes execution, review, and approval of maintenance work orders using the computerized manufacturing and maintenance system (CMMS).

The overall role of this manager is to maintain the integrity of Building Automation Systems and to ensure GMP compliance for Automation Systems, HVAC systems and building controls.

Monday – Friday, Onsite Day Shift, 8:00 a.m. – 5:00 p.m.

• Act as a technical subject matter expert for Building Automation Systems (QBAS / BAS).
• Collaborate with Stakeholders, Contractors and Automation service providers inclusive of IT for networking and system infrastructure issues.
• Serve as the primary liaison with Facilities & Engineering for successful execution of work orders and site automation projects.
• Ensure proper commissioning turnover and compliance of Automation related projects.
• Maintain overall Automation related suite of SOPs and Life Cycle Documents in compliance.
• Interface with internal and external stakeholders for service delivery related to Automation systems.
• Ensure compliance of Building Automation operations with a focus on areas with potential GMP impact including related Change Controls, Deviations & CAPAs.
• Respond to Customer requests in a professional and timely manner.
• Responsible for 7 day/week overall monitoring and reporting out Automation Alerts and Alarms for awareness to area owners.
• Provide cGMP oversight of external vendors to ensure they are operating within cGMP policies and site procedures.
• Assist in troubleshooting and emergency situations work OT when business requires.
• Maintain compliance of controlled environments, laboratory spaces and classified areas.
• Participate and take ownership of various compliance activities including: continuous improvement, deviations, root cause analysis, corrective actions, change control initiation, change action execution & proactive initiatives.
• Train colleagues as necessary and maintain required training completion adherence.
• Perform all work in accordance with established safety procedures.
• Act as Lead for new AI initiatives via site and global initiatives where applicable.

• Maintenance of Building Automation and HVAC systems. (Siemens Desigo Experience Preferred.)
• Instrumentation and controls used in Automation and HVAC systems.
• Must be competent in the use of CMMS to schedule, track and approve maintenance work.
• Must be capable of creating, reading and interpreting P&, electrical drawings and technical automation documentation.
• Must be familiar with the use of root cause analysis, five whys and basic six sigma troubleshooting techniques to support investigations and corrective actions.
• Experience using Computerized Maintenance Management Systems (CMMS).
• Use of root cause analysis (RCA) to resolve technical issues.

• Proficient in cGMP guidelines in accordance with company policy and procedures.
• Provide direct oversight of automation technicians and external vendors to ensure compliance.
• Provide daily oversight of Building Automation Technicians and Contractors.
• Coordinate routine maintenance and project work with Business Area Owners and Facility Planners.
• Review and approve documents related to additions and modifications to the Building Automation System.
• Provides oversight of GMP training curriculum for Automation technicians and external service…