Demo

Engineer (Mechanical) - Biotech Packaging Lines (JP13436)

3 Key Consulting
Albany, OH Full Time
POSTED ON 2/1/2025
AVAILABLE BEFORE 3/31/2025
Job Title:  Engineer, Biotech Packaging Line Mechanical  (JP13436)
Location: New Albany, OH.  43054
Business Unit: Assembly & Packaging
Employment Type:  Contract
Duration: 1 years (with possible extensions)
Rate: Open Market Rate/hour, W2 with Benefits
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 (Mechanical) - Biotech Packaging Lines 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.

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