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

Job Description

• 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
• Collaborates
• Situational Adaptability
• Communicates Effectively
• Customer Focus
• Organizational Savvy
• Plans and Aligns
• Resourcefulness

Equal Opportunity Employer