Senior Engineer – HVAC

With operations in 35 nations and 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza.

Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus.CSL Behring httpwww.cslbehring.com is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

CSL Behring operatesCSL Plasma httpwww.cslplasma.comcareers , one of the worldaposs largest collectors of human plasma, which is used to create CSLaposs therapies.

Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team Responsibilities Designs, develops and implements the manufacturing processes, instruments and equipment.

Analyzes and develops solutions to engineering problems related to manufacturing equipment and systems or the causes of component failures.

Develops and applies engineering standards and procedures, and provides advice on issues within the engineering field.

Qualifications Position Purpose 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 cGMPaposs in a Pharmaceutical Manufacturing facility.

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.

The Project Manager will lead projects of defined scope including the implementation of product process improvements, corrective preventative actions and change controls.

They will support cross functional teams for clinical and commercial manufacturing initiatives.

The individual will own projects and quality systems for manufacturing initiatives from initial planning and initiation, through implementation and closeout.

Main Responsibilities and Accountabilities 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 utilityfacility 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 IQOQ protocols, executions and summary reports.

Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (DesignFunctionalSystem) and updating PIDs.

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, FATapossSATaposs, 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 understandingproblem solving capability.

Complies with requirements from CSL Behringaposs Safety Program, including Health and Safety mandates and OSHA requirements.

Completes any other dutiesresponsibilities assigned by senior management.

Position Qualifications and Experience Requirements Education Bacheloraposs Degree in Mechanical Engineering preferred or B.S.

degree in an Engineering related field, with 8 years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility.

Experience Experience working in a Union environment is preferred but not required.

Must have experience with leading mid-to-large capital projects for the pharmaceutical industry.

Experience with architectural, MEP and PID drawings preferably in the pharmaceutical industry.

Be knowledgeable with respect to HVAC systems (air handling units, return fans, exhaust fans, air terminal devices, diffusers, grilles, refrigeration cycles and other air moving processes).

Be knowledgeable with respect to hydronic systems and air balancing methods.

Must have experience with executing test protocols for Freezer Coolers, Incubators, Clean Room Environments and HVAC Equipment in a FDA Regulated Environments.

Knowledge of biopharmaceutical process operation and process control, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation.

Knowledge of clean room designrequirements.

Working knowledge of pharmaceutical process sanitary connections, valves and supply loops.

Working knowledge of Process Control and Instrumentation for facility control systems.

Basic knowledge of programmable logic controllers (PLCs), instrumentation (e.g., flow, pressure, temperature, level) and controls is required.

Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.) Knowledge experience in the design, implementation, operations and maintenance of clean utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA).

Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, ISO standards and CFRaposs.

Experience working to regulatory standards FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP).

Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning Qualification Protocols Specifications, Validation Protocols.

Experience with Quality Management and Change Control Systems.

Ability to write technical reports and to develop data gathering schedules.

Ability to work on technical specifications and procurement details.

Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision.

Demonstrated ability to work with consultants and contractors, while interfacing with multiple departments, working with internal customers to manage projects, policy, and procedures.

Knowledge of computerized maintenance management systems (CMMS) and utility operations programs.

(SAP) Knowledge of building management systems (Emerson, Rockwell) Must work and interact effectively and professionally with others.

Must have effective oral and written communication skills.

Computer skills MS Office Suite, MS Project, and AutoCAD.

Competencies Drives Results Business Insight Collaborates Situational Adaptability Communicates Effectively Customer Focus Organizational Savvy Plans and Aligns Resourcefulness Capabilities Worker Type Employee Worker Sub Type Regular