Primary Utilities (Non-GMP) System Owner Engineer - Process Waste/Waste Water
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.
- 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.
- 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 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.
- Drives Results
- Business Insight
- Situational Adaptability
- Communicates Effectively
- Customer Focus
- Organizational Savvy
- Plans and Aligns
1201 N. Kinzie
CSL Behring Kankakee
Full Time/Part Time
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click below.