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.
...plastic part design, prototyping, engineering, and manufacturing capabilities. StackTeck Systems Ltd. is located 8 km north of Torontos Pearson International Airport. WHAT WE OFFER: Convenient location with quick 407 and 427 highway access and public transit to our...
...service, you don't have to wear the "many hats" of a typical Financial Advisor. Now is your opportunity to use your finance experience... ...'s degree or equivalent work experience ~ A thoughtful consultative approach with an emphasis on client focus Why Fisher Investments...
...It takes great medical minds to create powerful solutions that solve... ...us and put your expertise to work in ways you never imagined possible... ...-oriented and dependable Data Entry / Mail Room Clerk to join our... ...in a fully remote, work-from-home role. The ideal candidate will...
...CDL-A Trainee Truck Driver | Paid CDL Training | Little Rock, AR Get Paid to Launch Your Driving Career No CDL Experience Needed Take the first step into a high-demand industry with our paid CDL-A trainee program in Little Rock, Arkansas . Whether youre starting...
...Glance The Senior Brand and Product Manager will be a key driver of our brand's future, spearheading innovative brand and product marketing initiatives. This role demands a deep understanding of market dynamics and consumer behavior to craft compelling brand and product...