- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain our company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
- The Utility Operator 2 performs alarm monitoring, alarm response, utility operations, and routine monitoring required for GxP production activities and support.
- The operator will be responsible for actions resulting in safe, reliable, and consistent delivery of utilities.
- Key utility systems required for GxP production and support are RO, WFI, Waste Neutralization, HVAC, CDA, Steam, Heating Hot Water, Gases, and Power.
- The Utility Operations Operator 2 will interface cross-functionally with Instrumentation, Engineering, Compliance, EHS&S, Automation, Manufacturing, Quality Control, Reliability, and Maintenance as part of routine activities.
- This is swing shift position. Based on business needs, Operator 2 may be required to work other shifts to ensure operational continuity.
- Maintain positive relationships with key utility end users
- Represent the functional area in meetings and compliance activities
- Maintain integrated working relationships with key internal customers and cross-functional support groups
- Engage with key customers on an ongoing basis to identify changing needs
- Engage and interface with cross-functional groups for support and collaboration to resolve emergency, urgent, and non-standard issue
- Oversee vendors and contractors to ensure quality and effectiveness of services and deliverables.
Utility Monitoring and Operation
- Shadow and support senior operations staff as needed
- Perform remove from service, return to service, and system release activities
- Monitor equipment operation via multiple software applications and automated systems
- Regulate equipment and conditions to identified operational standards
- Perform effective and clear intragroup and intergroup shift pass downs and issue turnover
- Ensure effective and clear utility system status updates to all stakeholders
- Communicate operational changes to stakeholders via standardized communication plans
- Assist with performing trend evaluations of system operations to detect variations that will adversely impact system reliability and/or efficiency
- Monitor alignment to the identified utility service level and expected redundancy based on operational capabilities
- Conduct utility area rounds, and perform routine inspections to ensure inspection readiness
- Monitor and respond to alarms from multiple sources and platforms
- Initiate trouble calls to cross-functional support
- Track alarms to resolution and escalated to the most appropriate trade
- Turnover ongoing alarms between shifts, stakeholders, and other groups
Utilities Operation Program
- Participate in developing and reviewing SOPs and work instructions
- Participate in reviews and assessments for the Utility Operations program for continuous improvement
- Other projects/tasks as assigned by supervision.
- Engage in proper storage, handling, and disposal of chemicals
- Adhere to LOTO procedures
- Engage in safe behavior within the utility areas
- Active member of the company Emergency Response Team
General Skills and Knowledge:
- Ability to resolve problems or situations that require exercising tact, diplomacy and sound judgment.
- Ability to work with frequent interruptions and changes in priorities.
- Ability to acquire a thorough knowledge of workable systems, policies, and procedures
- Ability to maintain a positive attitude regardless of circumstances
- Ability to objectively support and explain reasoning for decisions
- Ability to become proficient with CMMS (INFOR preferred)
- Ability to objectively present data and identify key issues among many variables
- Knowledge of GxP maintenance and operational programs
- Basic understanding of utility equipment function to support steam, water, gas, and power
- Knowledge of safety practices and procedures
- Skill in problem solving
- Skill in oral and written communication
Education and Experience
- College degree (Associates/Bachelors), Technical Certification, military technical training, or equivalent experience that provides knowledge, skills, and the abilities required to appropriately perform the scope of responsibilities.
- At least 4 years’ experience related to utility and/or process equipment operation, maintenance, reliability, or instrumentation or an equivalent combination of education and experience is required.
- Experience with or experience monitoring alarms and automated controls (desired ).
- Basic Cause Mapping course completion within 12 months (required ).