SME Engineer – PSM (Process Safety Management) Systems
The Utilities Engineer is responsible for oversight of design, operational and troubleshooting support in one or more of the following utility equipment systems such as Ammonia Chillers, Refrigeration Process, Alcohol Distillation and Recovery Process, Process Gases, Bulk Chemical Distribution (Caustic and Acid solutions for clean in place systems) and the Solvent Gas Detection systems with knowledge of associated plant utilities.
The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation, and global engineering.
This position reports to: Manager, PSM Systems
- Responsible for providing engineering expertise to support the design, installation, commissioning, validation, and operation of the PSM utility systems.
- Focus on providing support for existing and new utility systems. Review and make recommendations to management for PSM utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning.
- Play an essential leadership role in the operation and troubleshooting of the PSM utility systems.
- Serve as the PSM utility subject matter expert. Provides technical expertise for all phases associated with utility/facility systems.
- Perform regular field walk-through tours and inspections and initiate any procedures necessary to resolve problems.
- Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives
- Continuously stay current with assigned SOPs and keep an up-to-date training file ensuring compliance with all applicable Standard Operating Procedures.
- Collect, analyze, and report data for use by the Utilities Engineering department to ensure reliable operation.
- Responsible for change controls, CAPAs, MOC’s, risk assessments, Safety and Regulatory Agency Audits.
- Provide guidance for support personnel and support development of LOTO/HECP programs.
- Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the PSM utilities system.
- Participate in validation activities including review of IQ/OQ protocols, executions, and summary reports.
- Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating P&IDs.
- Manage small-scale projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions.
- Provide support to the Global Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT’s/SAT’s, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications.
- Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup.
- Assist the Reliability Engineering department with developing predictive and preventative maintenance program for PSM utility systems.
- Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability.
- Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
- Bachelor’s Degree in Chemical or B.S degree in an Engineering related field.
- Three plus (3+) years of experience in an engineering role in Support of a large industrial, pharmaceutical, biotechnology of FDA regulated facility
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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