Sr Engineer - Clean Utilities
• 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)
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 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 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 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.
- 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 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 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 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 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:
Bachelor’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 regulated facility.
- 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 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 evaluation.
- 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 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, USP, EU GMP, ISO standards and CFR’s.
- 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.
- Drives Results
- Business Insight
- Situational Adaptability
- Communicates Effectively
- Customer Focus
- Organizational Savvy
- Plans and Aligns