Critical Utilities Technician - LOTTE BIOLOGICS USA, LLC

Position Summary

The Critical Utilities Technician will initially support the startup of the Antibody Drug Conjugate (ADC) utilities systems. After the commissioning and qualification of these systems, the role will transition to providing support for the Critical Utilities systems throughout the Syracuse Bio Campus.  The Critical Utilities Team is tasked with the maintenance, operation, and cleaning of Critical Utilities Systems, including Softened Water, RO Water, Water For Injection, Pure Steam, and Deionized Water systems. Their responsibilities encompass installing, repairing, troubleshooting, and performing preventive maintenance on various mechanical and control equipment.

Duties & Responsibilities

• Support Antibody Drug Conjugate (ADC) commissioning and qualification.
• Create Work Instruction (WIs), Standard Operating Procedures (SOPs), and job plans for the ADC critical utilities systems.
• Operate, maintain, and clean Critical Utilities Systems, including Water Pre-Treatment systems, Reverse Osmosis systems, Water For Injection systems, and Pure Steam systems.
• Troubleshoot, repair, install, and perform preventive maintenance on both GMP and non-GMP mechanical equipment such as drives, motors, and pumps.
• Provide off-hours support (nights, weekends, holidays) to ensure continuous operation of critical systems.
• Enter data from installations, preventive maintenance, failure information, and corrective actions into the CMMS (Maximo) System according to specified guidelines and procedures.
• Communicate clearly and concisely with team members, supervisors, and operations.
• Participate in Failure Modes Effects Analysis (FMEA) and Process Hazards Analysis (PHA) sessions.
• Operate through electronic maintenance work order management system, documenting all work electronically.
• Provide coverage for other critical utilities technicians during absences to maintain uninterrupted operation.
• Maintain assigned area of ownership within the facility for inspection readiness and general upkeep.
• Maintain a safe and clean work environment.
• Cross-train with the Reliability team to provide coverage as needed.
• Adhere to and enforce environmental, health, and safety procedures and policies.
• Operate within regulatory guidelines for documentation management, training compliance, deviation management, procedure adherence, and corrective/preventative action implementation.
• Learn how to conduct vibration and ultrasonic readings
• Ensure compliance with LOTTE policies, regulations, codes, and Standard Operating Procedures (SOPs).

Qualifications

• Proficient with power and hand tools.
• Experienced in using a CMMS system, Maximo preferred.
• Computer proficiency to interface with the Distributed Control Systems (DCS) for computerized control of mechanical systems.
• Capable of interpreting blueprints, P&IDs, and engineering drawings.
• Skilled in researching data from Original Equipment Manufacturers (OEM) manuals.
• Familiar with FDA, OSHA, and cGMP regulations.
• Knowledge of electrical and electronic equipment preferred.
• Effective communication skills with Operations and Maintenance staff.
• Experience in energy isolation and proper lockout/tag out of equipment.
• Experience with 5S/6S implementation and maintenance.
• Ability to independently troubleshoot equipment in a computer-controlled manufacturing environment

Education & Experience

• High School Diploma or equivalent is required
• Minimum of 3+ years industrial experience in mechanical trades

Work Environment

• This position may require the employee to work in areas where chemical, biologic, and environmental risks are present.
• This position is located at a medium scale manufacturing facility with classified areas requiring appropriate gowning and personal protective equipment (PPE).
• This role will require contact with hazardous materials such as caustic, acids and steam.

Physical Demands

• This position is located at a medium scale manufacturing facility with classified areas requiring appropriate personal protective equipment (PPE). This role will require contact with hazardous materials such as caustic, acids, and steam.
• Frequent bending, twisting, squatting, kneeling, climbing and reaching is required.
• Role also requires infrequent lifting (not to exceed 50 lbs.).
• This position is a team-based position that requires work Monday through Friday but may also require overtime, weekend, holiday support, and emergency call-ins.