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Senior Engineer, Biotech GMP New Line Packaging Operations (JP14555)
New Albany, Ohio · Biotech/PharmaceuticalJob Title: Senior Engineer, Biotech GMP New Line Packaging Operations (JP14555)
Location: New Albany, Oh 43054
Business Unit: Manufacturing Systems Engineering
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $65 - $85/hour DOE - W2 with benefits
Posting Date: 9/18/2025
Note: Candidates MUST be eligible to travel overseas for up to 16 weeks per year. Travel will be planned 2-3 weeks in advance. Fully Onsite - Standard Hours - Occasional overtime may be necessary on an as needed basis.
3 Key Consulting is hiring! We are recruiting a Senior Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Ideal Candidate: 4+ YOE, experience supporting a manufacturing line, and GMP or regulated environment experience.
Nice to have: relevant pharma experience, experience starting up a new manufacturing line.
Description:
In this role the Senior Engineer (Line Owner/System Owner) must work under general supervision, owns all the technical aspects in a manufacturing line. The processes where the SO/LO Engineer shall be familiar with are:
Day to Day Responsibilities:
Technical writing capability
Basic Qualifications:
Doctorate degree and 1+ years of experience OR Master’s degree and 3+ years of experience OR Bachelors degree and 5 years of experience OR Associates degree and 8 years of experience
Red Flags:
Any time at companies shorter than 6mo, although the hiring team understands some contracts are shorter.
Why is the Position Open?
Supplement additional workload on team
Interview Process:
Round 1 - 1 on 1 interview with hiring manager
Round 2 - Panel interview with 2-3 engineers/managers
We invite qualified candidates to send your resume to recruiting@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.
Location: New Albany, Oh 43054
Business Unit: Manufacturing Systems Engineering
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $65 - $85/hour DOE - W2 with benefits
Posting Date: 9/18/2025
Note: Candidates MUST be eligible to travel overseas for up to 16 weeks per year. Travel will be planned 2-3 weeks in advance. Fully Onsite - Standard Hours - Occasional overtime may be necessary on an as needed basis.
3 Key Consulting is hiring! We are recruiting a Senior Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Ideal Candidate: 4+ YOE, experience supporting a manufacturing line, and GMP or regulated environment experience.
Nice to have: relevant pharma experience, experience starting up a new manufacturing line.
Description:
In this role the Senior Engineer (Line Owner/System Owner) must work under general supervision, owns 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 design requirements to the service providers to fulfill area technical and equipment needs.
- 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.
- Experience in a manufacturing environment, preferably GMP regulated or other highly regulated environment
- Experience working hands-on to solve technical problems on manufacturing equipment
- Great communication skills
Day to Day Responsibilities:
- Act as the equipment technical subject matter expert for an end to end pharmaceutical device assembly and packaging line.
- This individual is responsible for working with the maintenance and automation teams to resolve complex issues that are escalated beyond the technician level.
- This individual also leads improvement projects to increase line OEE
- 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
Basic Qualifications:
Doctorate degree and 1+ years of experience OR Master’s degree and 3+ years of experience OR Bachelors degree and 5 years of experience OR Associates degree and 8 years of experience
Red Flags:
Any time at companies shorter than 6mo, although the hiring team understands some contracts are shorter.
Why is the Position Open?
Supplement additional workload on team
Interview Process:
Round 1 - 1 on 1 interview with hiring manager
Round 2 - Panel interview with 2-3 engineers/managers
We invite qualified candidates to send your resume to recruiting@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