Job Title: Engineer, Biotech Manufacturing Line (JP12155)
Location: New Albany, OH. 43054
Business Unit: Assembly & Packaging
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: $35 - $37/hour
Posting Date: 1/10/2024.
Notes: Only qualified candidates need apply. Fully onsite in New Albany OH. 43054 3 Key Consulting is hiring! We are recruiting an
Engineer Biotech Manufacturing Line for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description: In this role the Line Owner/System Owner must work under general supervision, owning all the technical aspects in a manufacturing line. The processes where 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.
Top Must Have Skill Sets: - 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 over an industrial engineer (industrial is OK with relevant experience)
Day to Day Responsibilities: 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.
Basic Qualifications: Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of 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 Context
Why is the Position Open? Supplement additional workload on team.
Red Flags: Misspellings in Resume. Long Resumes without descriptive content.
Interview Process: One phone and one virtual panel interview. 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