An engineering professional that works with project engineers, stakeholders, and other project team members to complete tasks associated with commissioning and qualification of new or modified equipment, facilities, and utilities. The main objective of commissioning is to ensure the safe and orderly handover of the unit from the constructor to the owner, guaranteeing its operability in terms of performance, reliability, safety, and information traceability. When executed in a planned and effective way, commissioning normally represents an essential factor for the fulfillment of schedule, costs, safety, and quality requirements of the project. Responsibilities:
- Work with end-user and project engineer to develop User Requirements Specifications and Functional / Design Specifications for new or modified equipment, facilities, and utilities.
- Coordinate Factory Acceptance Testing in conjunction with Project Engineer to confirm unit is acceptable.
- Identify critical elements of equipment design based on FMEA or other risk assessment.
- Develop and execute commissioning test protocols to ensure that the unit functions according to specifications.
- Perform minor troubleshooting of issues encountered during commissioning and documentation of unresolved issues.
- Work with technical writers and system owners to develop operational procedures.
- Responsible for training of maintenance, technical staff, and operators on new equipment where appropriate.
- Review new or modified product documentation to ensure compatibility with qualified equipment and implement changes in equipment parameters or recipes.
- Contribute to the development of commissioning and qualification best practices.
- Bachelor's Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3+ years of significant engineering and/or operational experience.
- A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
- Experience in the development of commissioning and qualification deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
- Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
- A basic understanding of government regulations such as FDA cGMPs.