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Engineer, Biotech Manufacturing Line
Engineer, Biotech Manufacturing Line3 Key Consulting • New Albany, OH, United States
Engineer, Biotech Manufacturing Line

Engineer, Biotech Manufacturing Line

3 Key Consulting • New Albany, OH, United States
30+ days ago
Job type
  • Full-time
Job description

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 resumes@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

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    Manufacturing Engineer • New Albany, OH, United States