Primary Utilities (Non-GMP) System Owner Engineer - Process Waste/Waste Water

Employer
CSL Behring
Location
Kankakee, Illinois
Posted
Nov 14, 2020
Ref
R-124597
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 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 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 operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies 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!

Job Description

The Utilities Engineer is responsible for oversight of design, operational and troubleshooting support for the utility distribution systems with primary focus on the water/wastewater treatment, pumping stations and collection/distribution systems with strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility.

The Engineer will serve as a lead for utilities engineering between manufacturing, automation, quality assurance, EHS and operations.

Experience with other Plant Utilities is a plus.

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

Responsibilities:
  • Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the plant water/waste water treatment and associated systems.
  • Diagnoses operating issues and make necessary adjustments to the process including biological, chemical and mechanical systems.
  • Perform calculations for proper mixture, chemical flow rate based on engineering principles maintaining compliance to federal, state, and local regulations.
  • Participates in operations activities to review, analyze, and interpret environmental monitoring data. Assist with environmental laboratory technical studies, which may include reviewing sample collections, laboratory tests and analyses.
  • Performs data evaluation, design support, assist with reviewing hydraulic analysis and modeling of water and wastewater systems.
  • Serve as the primary 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.
  • Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits.
  • Must follow safety rules and ensure compliance with state, local and federal EPA regulation and laws.
  • Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the utility system.
  • Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating P&IDs.
  • Support 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.
  • 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 Chemical Engineering or an Engineering related field, with 3+ years of wastewater and environmental compliance 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 mid-to-large capital projects for the pharmaceutical industry.
  • Be knowledgeable with respect to the chemical and biological processes in water and wastewater treatment.
  • Be knowledgeable with respect to the operation and maintenance of various waste treatment equipment including blowers, carbon dioxide, aerobic and anaerobic biological basins, centrifuge, polymer blending units and dissolved air floatation.
  • Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry.
  • Knowledge of biopharmaceutical process operation and process control, utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation.
  • 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 utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA).
  • Strong knowledge of industry standards and guidelines.
  • 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.
  • 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