Requirements Education / Experience
Master’s degree OR Bachelor’s degree in engineering & 2 years of Engineering experience
Bachelor’s Degree in Mechanical, Electrical or Chemical Engineering
2+ years’ experience in engineering, reliability engineering or maintenance.
- Knowledge and experience with operation and maintenance of complex electro-mechanical equipment and systems.
- Knowledge and experience with fluid transfer systems including valves, pumps, piping and pressure vessels.
- Demonstrated skills, knowledge and experience utilizing a computerized maintenance management system. Experience with Maximo preferred.
- Position requires excellent written and verbal communication skills and the ability to work with minimum direction. English and Spanish
- Demonstrated planning and organizational skills.
- Solid Industrial Safety background
Plant Engineer – System Owner – Reliability Engineer
The System Owner and Reliability Engineer will perform maintenance support activities for existing and new manufacturing equipment, provide technical expertise on their maintenance strategy and track equipment performance metrics.
Specific duties include:
- CMMS (MAXIMO) Equipment Ownership
- Provide technical expertise to define and implement equipment maintenance strategies while optimizing cost, compliance, and effectiveness.
- Collaborate with Facilities and Engineering staff to ensure the best maintenance strategy on manufacturing equipment is aligned with current operations.
- Revise and own spare parts lists for new equipment and add to the CMMS.
- Develop preventive maintenance strategy and instructions and implement in the CCMS.
- Equipment performance metrics (ex. Downtime, OEE, etc.)
- Ensure maintenance instructions are accurate, effective and support compliance with applicable regulations.
- CMMS and reliability change control assessment and requirements
- Review SOP related to equipment
- Work order closing ownership
- Assist with development of Lock Out Tag Out Procedures for new equipment.
- Other maintenance support activities required to facilitate addition of new and modified equipment to the maintenance program.
Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.
Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity
- Provide solutions to a variety of technical problems of moderate scope and complexity.
- Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
- Perform assignments that have clear and specific objectives and require investigation of limited number of variables. (*)
- Initiate and complete routine technical tasks.
- Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems. (*)
- Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity. (*)
- Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications. (*)
- Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints. (*)
- Work with consultants, architects and engineering firms on development of standard design documents. (*)
- Obtain and critique quotes for equipment modifications or installations.
- Generate rudimentary project cost estimates and schedules.
* Other functions may be assigned
Master’s degree OR Bachelor’s degree in Engineering & 2 years of Engineering experience
- Working knowledge of pharmaceutical/biotech processes
- Familiarity with validation processes
- Familiarity with documentation in a highly regulated environment
- Ability to operate specialized laboratory equipment and computers as appropriate.
- Ability to interpret and apply GLPs and GMPs.
- Ability to apply engineering science to production.
- Able to develop solutions to routine technical problems of limited scope
Demonstrated skills in the following areas:
- Problem solving and applied engineering.
- Basic technical report writing
- Verbal communication
- Comprehensive understanding of validation protocol execution requirements.
Demonstrated Skills in the following areas:
- Basic technical presentations
- Personal Organization
- Validation Protocol Writing
- Dealing with and managing change
- Technical (Equipment Specific)
- Analytical Problem Solving
- Computer Literacy