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 ...@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,3KC Talent Acquisition Team