Job Title: Engineer Senior, Biotech Manufacturing/GMP (JP10745)
Location: New Albany, Ohio 43054
Employment Type:  Contract to Hire
Business Unit: Final Product Technologies CORE
Duration: 2+ years (with likely extensions and/or conversion to permanent)
Posting Date: 8/26/22
Notes: Only qualified candidates need apply.  Onsite.  25% travel


3 Key Consulting is hiring an Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The Engineer position reports into the Senior Manager Engineering under Process Development at our client’s New Albany, OH. facility. This position requires the application of diverse and advanced engineering and scientific principles in support of Final Drug Product (FDP) commercial GMP operations at AOH.  The position is expected to travel for approximately 25%.

FUNCTIONS

The Engineer will support the development and implementation of technical solutions for a variety of engineering initiatives supporting the FDP commercial GMP operations at AOH. The position is a key role in the Process Development group and the candidate must manage and/or apply extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, validation, maintenance and alteration of systems, facilities and/or processes. 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 characterization, optimization, scale up or manufacturing support projects.

OUTPUTS

Project Management:
Key responsibilities will include supporting the Technical Transfer of the client’s product portfolio to AOH. Additional responsibilities will include the provision of technical operations support for the continuous improvement of packaging lines capacity and performance, and advisory of technical improvement projects. The Engineer must ensure effective communication throughout the client’s commercial site network with all stakeholders and deliver on technical improvements.

Technical Support:
Act as a subject matter expert for FDP GMP operations at AOH, and primarily as technical support for new process equipment and technology. This will include GMP process equipment design, testing, characterization and validation. The Engineer will author such documents as well as be responsible for the execution of said protocols. The Engineer is expected to use technical process knowledge and identify the required expertise to resolve process challenges as needed.

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

RELATIONSHIPS

The Engineer is expected to build a network of FDP expertise within AOH and across other client commercial operations for product assembly, label and packaging. The position is expected to leverage this network in support of technical expertise for equipment design, testing, characterization and validation at AOH.

Why is the Position Open?
Planned Project.

Top Must Have Skills:

• 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 technical solutions for a variety of engineering initiatives supporting the FDP commercial GMP operations at AOH.
• The position is a key role in the Process Development group and the candidate must manage and/or apply extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, validation, maintenance and alteration of systems, facilities and/or processes.
• 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 characterization, optimization, scale up or 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.
• Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
• Proven track record of contributing to cross-functional projects.
• Strong teamwork, excellent interpersonal and communication skills.
• Experience with devices/combination products and the associated manufacturing process.
• Experience of working with 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!

Employee Value Proposition:
Greenfield project to support a new assembly site in OH.

Interview process:
Phone interview with Director of Process Development, Sr. Manager Process Development and Sr. Engineer Process Development


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.