SME Engineer - Clean Utilities
Company: CSL Behring
Posted on: November 23, 2022
Job Description--- Under general supervision supports utilities
operations (plant and clean utility, ethanol, HVAC) --- Ensures
operations comply with cGMP and company standards for quality,
health, safety and the environment --- Investigates plant failures
and operating incidents, determines cause and recommends and
implements solutions --- Analyzes maintenance history, waste and
energy usage and process models and recommends improvement plans
--- Provides technical support, project briefs, system requirements
and preliminary budgets for facility modifications, upgrades and
capital projects --- Maintains quality standards, risk assessments
and CSL standard operating procedures (SOPs) Position Purpose:The
Utilities Engineer is responsible for oversight of design,
operational and troubleshooting support for the clean utility
distribution systems that include WFI, RO, Purified Water, Clean
Steam and Process Gases 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 project engineering.
This individual will work closely with a cross-functional team to
meet the needs of the groups they support.Main Responsibilities and
- 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 clean
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 clean utility systems.
- Serve as the clean utility subject matter expert. Provides
technical expertise for all phases associated with utility/facility
- 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
- Collect, analyze and report data for use by the Utilities and
Operations department to ensure reliable operation.
- 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
- 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
- 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
- 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.Position Qualifications and Experience
Requirements:EducationBachelor's Degree in Chemical or 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
- Experience working in a Union environment is preferred but not
- Must have experience with leading mid-to-large capital projects
for the pharmaceutical industry.
- Experience in new facility start-up, large scale equipment
package vendor management, and FAT execution and coordination.
- Experience with architectural, MEP and P&ID drawings
preferably in the pharmaceutical industry.
- Knowledge of biopharmaceutical process operation and process
control, clean utility and mechanical systems (pumps, valves,
materials) as foundation for troubleshooting, design and equipment
- Knowledge of CIP/SIP, clean room design/requirements. 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, conductivity, UV) and controls is
- Must possess basic knowledge of core principles in various
engineering disciplines (fluid mechanics, heat transfer,
- 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, USP, EU GMP, ISO standards and
- 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,
- Experience with Quality Management and Change Control
- Ability to write technical reports and to develop data
- Ability to work on technical specifications and procurement
- 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,
- Must work and interact effectively and professionally with
- Must have effective oral and written communication skills.
- Computer skills: MS Office Suite, MS Project, and
- Drives Results
- Business Insight
- Situational Adaptability
- Communicates Effectively
- Customer Focus
- Organizational Savvy
- Plans and Aligns
- ResourcefulnessAbout UsOur BenefitsWe encourage you to make
your well-being a priority. It's important and so are you. Learn
more about how we care at CSL.About CSL BehringCSL 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 .We want CSL to reflect the world around
usAs a global organisation with employees in 35+ countries, CSL
embraces diversity, equity and inclusion. Learn more about
Diversity, Equity & Inclusion at CSL.Do work that matters at CSL
Keywords: CSL Behring, Joliet , SME Engineer - Clean Utilities, Engineering , Kankakee, Illinois
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