This job is currently Archived,
Posted on : 04 April 2017
- Our Romany 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.
- Our company leads the biotechnology industry in delivering therapies for chronic and degenerative genetic conditions that reduce patients' quality of life and shorten life spans. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- Our company will continue to focus on advancing therapies that are the first or best of their kind and make a big difference in improving patients' lives.
- This is a swing shift position. Depending on business needs, personnel may be required to work other shifts to support business continuity.
- The Utility Operations Sr. Operator 2 will be a technical leader, and will serve as an Utility Operations subject matter expert for cross-functional support
- and training of junior operators. The operator will be a key participant in continuous improvement and maintaining service level agreements with stakeholders.
- The Utility Operations Sr. Operator 2 may perform or train others to perform alarm monitoring, alarm response, utility operations, and routine monitoring for activities including GxP.
- The Utility Operations Sr. Operator 2 is responsible for safe, reliable, and consistent delivery of utilities. Key utility systems include RO, WFI, Waste Neutralization, HVAC, CDA, Steam, Heating Hot Water, Gases, and Power.
- The Utility Operations Sr. Operator 2 will interface cross-functionally with Instrumentation, Engineering, Compliance, EHS&S, Automation, Manufacturing, Quality Control, Reliability, Maintenance, vendors
- and contractors as part of routine activities.
- Foster and maintain positive relationships with end users, customers, and cross-functional support groups
- In absence of supervisor, represent Utility Operations in meetings and compliance
- Continually engage customers to identify changing needs
- Collaborate with appropriate group(s) to resolve emergency, urgent, and non-standard issue
- Oversee vendors and contractors to ensure quality services and deliverables.
Utility Monitoring and Operation
- Review operation and monitoring practices of group to identify areas for improvements
- 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 systems status and any rationale for operational changes to stakeholders via standardized communication plans
- Evaluate system operational trends to detect variations that adversely impact system reliability and/or efficiency
- Assist supervision to develop, assess, and use KPIs and other leading indicators to assess operational performance
- 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
- Proactively manage impacting or potentially impacting issue or events
- Participate in SAT s and commissioning of new utility equipment.
- Review responses of group to identify areas for improvements or training gaps
- Prioritize alarm monitoring and response dispatch based upon utilities status and demand
- Identify, assess, respond, and resolve alarm response errors, issues, or inconsistencies by operations staff
- Assist supervision with maintaining alarm response metrics and KPIs for response continuous improvement
- Initiate trouble calls to cross-functional support
- Communicate any proposed appropriate solutions for system readiness lapses
- Ensure alarms are tracked to resolution and escalated to the most appropriate trade
- Ensure turnover of ongoing alarms to between shifts, stakeholders, and other groups
Utilities Operation Program
- Lead adjustments of day to day activities to improve group responses and achieve service levels
- Attend cross-functional SME meetings such as the Utilities Robustness Improvement Team, Tactical Strike Teams, and Engineering Forums
- Develop and review SOPs and work instructions
- Participate in reviews and assessments for the Utility Operations program for continuous improvement
- Other projects/tasks as assigned by management.
- 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 mentor, train, coordinate, and evaluate work of entry level operators
- 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 oversee vendors and consultants
- Proficiency with CMMS (INFOR preferred)
- Ability to objectively present data and identify key issues among many variables
- Knowledge of GxP maintenance and operational programs
- Knowledge and understanding of utility and process equipment function to support steam, water, gas, power, fermentation, purification, and environmental chambers
- 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 8 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 (required )
- Train the Trainer course or course completion within 6 months (required)
- BMRN Innovation and Influence Course or completion within 6 months (required)
- Basic Cause Mapping course or course completion within 6 months (required )
- Instrumentation and Control basic familiarity (preferred)
- Mentoring courses or formal mentor experience (advantage)
- Continuous improvement course work of experience (advantage)
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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