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Job Description:

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

_Disclaimer:_

_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_