Onsite fully onsite

• Standard business hours with some opportunity for overtime
• Department is responsible for maintaining pharmaceutical packaging line equipment and improvement projects to the packaging line process
• EWs will come in and support packaging line equipment in place
• Least 3-5 years of experience but *seeking 5-10 years of experience*
• This needs to be a senior level leader, please ensure this is identified also in soft skills with your screening process

• Mechanically equipped is a must have

• Familiar with operations/ working with the operators is a must have

• Will talk to equipment vendors about issues/ ticket escalation and submission

• Experience with medical devices, syringes, vials

• We are NOT looking for a validation engineer- we are looking to a technical/ packaging engineer with mechanical skills

• NO upstream formulation this team receives the inspected drug product unlabeled

In this role the 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 designs requirement 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