Job Description

Title: Engineer - System Owner - Packaging Equipment Engineer

Location: New Albany, OH

Duration: 06+Months

Engineer - System Owner - Packaging Equipment Engineer

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

Top 3 Must Have Skill Sets:

• 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

• We are not looking to fresh out of school, should have at 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

Day to Day Responsibilities:

100% onsite in New Albany, Ohio

Work with operations to ensure equipment is operating correctly.

Work with maintenance on equipment breakdowns.

Write / Update documents related to equipment and maintenance.

Attend meetings

Improve equipment performance through continuous improvement projects.

Lead small projects for packaging line improvements.

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