SME Engineer - Utilities

The Utilities Engineer is responsible for oversight of operational and troubleshooting support for the HVAC system distribution with strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility. Experience with other Plant Utilities (Boilers, Chillers, Cooling Towers, etc.) is a plus.

The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation and project engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support.

Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the clean utility systems.

Focus on providing support for existing and new utility systems. Review and make recommendations to management for utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning.

Responsible for cGMP facility design and improvement projects (Cleanrooms, Labs, ISO classes, HVAC, Refrigeration, Freezers, Environmental rooms, etc). Play an essential leadership role in the operation and troubleshooting of the utility systems.

Serve as the 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 and Operations department to ensure reliable operation. Periodically review and assist with Building Air Balance Testing.

Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits.

Provide guidance for support personnel and helps drive development of PM programs.

Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the clean 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 capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions.

Provide support to the Capital 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 with developing predictive and preventative maintenance program for 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.

Completes any other duties/responsibilities assigned by senior management.

Education:

Bachelor’s Degree in Mechanical Engineering preferred or B.S. degree in an Engineering related field, with 5+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility.

Experience:

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

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.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.