Apply to Engineer (Mechanical) - Biotech Packaging Lines (JP13436)

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.