Job Title:  Engineer - Packaging (JP12190)
Location: New Albany, OH. 43054
Business Unit: Manufacturing Science and Technology
Employment Type:  Contract
Duration: 1+ years (with possible extensions)
Rate: $32 - $37/hour plus benefits
Posting Date: 1/30/2024.
Notes: Only qualified candidates need apply.  Fully onsite in New Albany OH. Day shift.  20% travel expected.


3 Key Consulting is hiring!  We are recruiting an Engineer Senior, Sustainability for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
The Senior Engineer position reports into the Sr, Manager of Process Development. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations in the client’s Ohio facility.

Functions and Outputs:
The Senior Engineering will support the development and implementation of automated and semi-automated combination product assembly equipment initiatives as part of the Finished Drug Product (FDP) product portfolio at the client’s Ohio manufacturing site. The position is a key role in the Process Development team where the candidate must manage and/or apply extensive technical expertise (characterization, validation and troubleshooting) in the assembly of combination products. This position will also be required to apply advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process optimization, scale up and manufacturing support projects.

Project Management:
Key responsibilities will include supporting the Technical Transfer of the Client product portfolio to AOH. Additional responsibilities will include the provision of technical operations support for the continuous improvement of device assembly and packaging line capacity and performance, and advisory of technical improvement projects. The Sr. Engineer must ensure effective communication throughout the Client Ohio commercial site and Client network with all stakeholders and deliver on technical deliverables.

Technical Lead:
Act as the site technical expert for automated and semi-automated device assembly for FDP and non-combination products. Be the technical expert for new process and existing device assembly technology. The candidate is expected to use technical process knowledge and identify the required expertise to resolve process challenges as needed. Technical expertise in combination product assembly is required.

The candidate will also be responsible for leading the Commissioning, Qualification and Validation of process and GMP equipment located at AOH. They will own the site master validation plan for GMP equipment and will be responsible to the maintenance and execution of this.

Operational Excellence:
Responsible for supporting the delivery of productivity, throughput, and general capacity improvements across the AOH site by analyzing, designing, and implementing manufacturing and business process improvements.

Relationships:
The Senior Engineering is expected to build a network of FDP expertise across the Client commercial and clinical operations for product assembly, label and packaging. The position is expected to leverage this network in support of GMP technical expertise, performance trending, equipment standardization and troubleshooting/process improvements at AOH.


Top Must Have Skill Sets:

• Knowledge of combination product assembly equipment and applicable testing
• GMP process equipment design, testing, characterization and validation

• Will work on packaging and medical device equipment.

Day to Day Responsibilities:
The Engineer will support the development and implementation of automated and semi-automated combination product assembly equipment initiatives as part of the Finished Drug Product (FDP) product portfolio at the Client Ohio manufacturing site. The position is a key role in the Process Development team where the candidate must manage and/or apply extensive technical expertise (characterization, validation, and troubleshooting) in the assembly of combination products. This position will also be required to apply advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process optimization, scale up and manufacturing support projects.

Basic Qualifications:

• Master’s degree and/or 2 years of working in a GMP regulated environment.
• Bachelor’s degree and/or 5 years of working in a GMP regulated environment.
• Knowledge of combination product assembly equipment and applicable testing.
• Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
• Proven track record of leading and executing cross-functional projects.
• Strong teamwork, excellent interpersonal and communication skills.
• Direct experience with the manufacturing process for devices, combination products and label & packaging operations.
• Experience of working with Final Drug Product equipment suppliers.
• Ability to work in a highly regulated and ever-changing industry.
• Ability to learn and rapidly adapt to new requirements in a fast-moving environment.
• An Operational Excellence approach to work product – driving rapid results.
• A passion to deliver an excellent work product and develop others with an infective positive attitude!

Why is the Position Open?
Planned project.

Red Flags:
No packaging/ medical device experience

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.