**Job Details:** **Duration: 12-month contract** **Summary:** + In this role, the Line Owner/System Owner must work under general supervision and owns all the technical aspects in a manufacturing line. The processes that the SO/LO Engineer shall be familiar with are characterization of process optimization strategies and/or solving problems of operational issues in the packaging operations, manufacturing, pilot technologies or capital projects. + 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. + As a technical resource of an area, the System Owner / Line Owner Engineer shall interact and provide direction to technical resources such as Mechanics, Automation Techs, and IS teams. At the same time, the System Owner/Line Owner Engineer shall be able to define design requirements to the service providers to fulfill area technical and equipment needs. **Specific responsibilities include, but are not limited to:** + 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 the investigation of a limited number of variables. + Initiate and complete routine technical tasks. **Operations Engineering:** + Function as a technical specialist in equipment or systems regarding problem-solving operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve problems. + Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of complexity. + Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance, and/or validation departments in developing requirements and recommendations for system modifications. **Design Engineering:** + 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 the development of standard design documents. + Acquire and critique quotes for equipment modifications or installations. + Generate rudimentary project cost estimates and schedules. **Preferred Qualifications:** + Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering + Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations + Knowledge of pharmaceutical/biotech processes + Familiarity with validation processes for Packaging areas + Familiarity with serialization process and networking + Familiarity with documentation in a highly regulated environment + Ability to operate specialized equipment, tools and computers as appropriate. + Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment. + Ability to apply engineering science to production. + Able to develop solutions to routine technical problems of limited scope + Comprehensive understanding of protocol requirements. + Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability + Excellent communication (verbal/written) and presentation skills + Demonstrated interpersonal skills including; collaboration, influencing, and facilitation + Protocol and script testing Writing + Packaging Equipment Technical knowledge + Comprehensive understanding of validation protocol implementation requirements as well as knowledge of validation processes and requirements as applied to new equipment installations + Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Contex **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com (http://www.ustechsolutionsinc.com) . US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.