Senior Engineer, Biotech Manufacturing/Packaging Lines (JP14376)

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:

• 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.
    

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 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 [email protected] . 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 You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.