4150 Ganton Parkway New Albany, OH 43031 US
Pay range is $27 - $32 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
Top 3 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***
- No packaging/ medical device experience
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 Ohio facility.
Location Options: AOH.
The position is expected to travel for approximately 20%.
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 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 trouble shooting) 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.
Key responsibilities will include supporting the Technical Transfer of the company 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 Ohio commercial site and our network with all stakeholders and deliver on technical deliverables.
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.
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.
The Senior Engineering is expected to build a network of FDP expertise across the 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.
- 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 team work, 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!