Ideal Candidate: 4+ YOE, experience supporting a manufacturing line, and GMP or regulated environment experience. Nice to have: relevant pharma experience, experience starting up a new manufacturing line.

In this role the Senior Engineer (Line Owner/System Owner) must work under general supervision, owns all the technical aspects in a manufacturing line. The processes were 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, 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 investigation of limited number of variables. • Initiate and complete routine technical tasks. Operations Engineering: • Function as a technical specialist to 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 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 • Dealing with and handling change • Packaging Equipment Technical knowledge • Analytical Problem Solving • 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