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.
...Mission Foods is currently seeking a skilled Product Manager for their Fresno, CA location. The Product Manager will be responsible for overseeing the daily operations of the Flour Department. They will serve as a liaison between upper management and line employees, ensuring...
Introduction Welcome to Thind Management,afamily-owned management company where we strive to provide exceptional service and unforgettable experiences to our guests at ourproperties. With a passion for hospitality and a commitment to teach, we at Thind Management strive...
...an impact in one of the worlds most prominent news organizations? News Corps The US Sun is seeking freelance Digital News Reporters to join our team. Dive into a fast-paced newsroom and cover everything from breaking news to consumer stories, entertainment, motoring...
HSE Clerk Now Hiring: HSE Clerk | Cypress, TX | $22?$26/hr Industry: Oil & Gas Manufacturing | Position Type: Full-Time | Location: On-Site Are you detail-oriented and experienced in health, safety, and environmental documentation? We?re looking for an organized...
Boyd Gaming Corporation has been successful in gaming jurisdiction in which we operate in the United States and is one of the premier casino entertainment companies in the United States. Never content to rest upon our successes, we will continue to evolve and retain...