Job Description

Job Description

Job Title: Packaging Engineer/Equipment Engineer

Location: New Albany OH

Duration: 12+ Months

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

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