SME Engineer - Utilities
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!
The Engineer is responsible for improving the reliability of equipment, utilities, critical systems and maintenance processes by applying the principles of Reliability Centered Maintenance. Apply Root Cause Analysis methodologies to improve equipment that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. Measure reliability performance and demonstrate success of improvements. Lead reliability driven actions that require independent and/or collaborative judgment.
The responsibilities include support of the day to day operations of the department, overseeing and support of projects and long-term implementation of equipment lifecycles. Deliver compliant and robust engineered solutions to improve reliability and efficiency of systems and equipment based upon operational best practices and periodic reviews.
Leads Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA).
Lead Reliability Centered Maintenance Improvement (RCM) or other improvement projects in multiple areas.
Develop the maintenance strategy, plans, SOPs, parts lists, BOMs and frequencies for new and modified equipment.
Responsible for asset lifecycle management
Provide necessary support to production and facility personnel to address all compliance issues and to ensure equipment is maintained at a level required to provide high reliability and to maximize useful life.
Ability to communicate clearly and accurately, verbally and in writing and a strong understanding and knowledge of engineering and maintenance functions.
Reviews engineering specifications and drawings, proposing design modifications to improve reliability within cost and other performance requirements
Participate and provide support for audits.
Lead, participate, and provide subject matter expertise in the design review and selection of new equipment.
Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment. Improve Equipment Parts Lists and BOMs accuracy in collaboration with MRO
Data analysis of corrective work orders in CMMS and Quality Event Metrics to identify trends and identify areas of improvements
Participate in FAT, Commissioning of new and modified equipment
Perform functional equivalency assessment of spare parts.
In collaboration with engineering, manufacturing, and maintenance personnel lead, perform or support troubleshooting of equipment.
Participate and provide support for audits.
Develop business case for improvements requiring investments and participate in capital planning for assigned area.
Develops engineering solutions to repetitive failures and all other problems that adversely affect plant operations, which may include capacity, quality, cost, or regulatory compliance issues, by applying data analysis techniques (statistical process control, reliability modeling and prediction, fault tree analysis, Six Sigma (6σ) methodology, etc.), root cause analysis (RCA) and root cause failure analysis (RCFA), and failure reporting, analysis, and corrective action system (FRACAS)
Supply engineering expertise in the specification, design, and construction of projects in accordance with plant design requirements, CSL standards, and regulatory requirements
Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
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 an Engineering related field, with 3+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility.
- Certified Maintenance & Reliability Professional, preferred Certified Reliability Engineer, preferred
- Experience working in a Union environment is preferred.
- Demonstrated knowledge of Reliability Engineering concepts such as TPM, RCM, RBI, FMEA and RCFA experience with process improvement principles such as Lean and/or Six Sigma.
- Proficiency in Power BI is a plus
- Demonstrated experience in bioprocess engineering and expert knowledge of systems/equipment/facilities/automation is required.
- Excellent communication, technical, organizational, leadership, and mentoring skills are required.
- Must be a team player prepared to work in and embrace a team-based culture experienced in operations leadership
- Experience working in a Lean or Value Stream environment
- Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR's.
- Knowledge & experience in the design, implementation, operations and maintenance of utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA).
- Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry.
- Experience with Quality Management and Change Control Systems.
- Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision.
- "Hands-on" approach in managing support of manufacturing and facilities equipment.
- Knowledge of SAP maintenance management systems.
- Must work and interact effectively and professionally with others.
- Must have effective oral and written communication skills.
- Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Computer skills: MS Office Suite, MS Project, and AutoCAD.