What are the responsibilities and job description for the Senior Engineer, Biotech Manufacturing/Packaging Lines (JP14376) position at 3 Key Consulting?
Job Title: Senior Engineer, Biotech Manufacturing/Packaging Lines (JP14376)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Manufacturing Systems Engineering
Duration: 1 years with likely extensions and/or conversion to permanent
Posting Date: 08/07/2025
Pay Rate: $40 - $46/hour W2 with benefits
3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical 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.
Job 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 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.
Apply 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.
Specific responsibilities include but are not limited to:
Why is the Position Open?
Supplement additional workload on team
Top Must Have Skills:
Day to Day Responsibilities:
Basic Qualifications:
Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience.
Employee Value Proposition: Leading Biotech Experience
Red Flags:
Any time at companies shorter than 6mo, although the hiring team understands some contracts are shorter.
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 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.
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Manufacturing Systems Engineering
Duration: 1 years with likely extensions and/or conversion to permanent
Posting Date: 08/07/2025
Pay Rate: $40 - $46/hour W2 with benefits
3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical 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.
Job 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 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.
Apply 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.
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.
-
- 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.
- 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 Contex
Why is the Position Open?
Supplement additional workload on team
Top Must Have Skills:
- 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.
Basic Qualifications:
Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience.
Employee Value Proposition: Leading Biotech Experience
Red Flags:
Any time at companies shorter than 6mo, although the hiring team understands some contracts are shorter.
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 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.
Salary : $40 - $46