Biotech Process Development Jobs in Ohio (NOW HIRING)

Job Title: Packaging Equipment Engineer, Biopharma Assembly & Packaging (JP12210)
Location: New Albany, OH 43054
Employment Type: Contract/C2H
Business Unit: Assembly & Packaging Chimera
Duration: 1 year with likely extensions and/or conversion to permanent
Rate: Market Rate DOE
Posting Date: 01/23/2024
3 Key Consulting is hiring a Packaging Equipment Engineer - System Owner for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
n 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.
Top Must Have Skills:

• Experience with packaging equipment, specifically pharmaceutical, food, or beverage.
• Experience with GMP environments.
• Good communication skills, troubleshooting skills, and a team player.
• Looking for Mechanical engineer ? industrial engineer (industrial is OK with relevant experience)

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
Employee Value Proposition: Unique industry experience
Red Flags:
Misspellings in Resume
Long Resumes without descriptive content
Interview process:
HM - 30 Minutes
Panel - 45 Minutes
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com . If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards,