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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