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Senior Process Engineer, Print Operations
2 months ago
United Therapeutics - Senior Process Engineer, Print Operations - Manchester, New Hampshire
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
The Senior Process Engineer is responsible for providing expertise in process engineering design and ongoing process improvements. The Senior Process Engineer will contribute to the development and implementation of internally transferred technologies for scale up and production operations. This role will also be responsible for analyzing and documenting the results of experiments to prepare for tech transfer to manufacturing (GMP).
Liaise with R&D teams to document standard methods and internally transferred processes related to scale up, production, and GMP tech transfer, e.g. SOPs, work instructions, test plans, and inspection methods
Implement and maintain documentation, data analysis, and data structures pertinent to print operations work flows
Lead select print operation team efforts including scale up, production, optimization/continuous improvement of processes, troubleshooting and change management
Liaise with internal and external teams to achieve process feasibility, process development, and process validation project objectives
Work independently to ensure compliance to specifications and report abnormalities
Support all processes of 3D print operations as needed, including QC testing, solution mixing, 3D printing, and post processing
Perform all other duties as required
For this role you will need
Bachelor’s Degree in materials science, chemistry, chemical, mechanical or biomedical engineering (or related) with 5+ years of experience or 3+ years of experience in materials science, chemistry, chemical, mechanical or biomedical engineering (or related) with a Master's Degree
2+ years of experience with SLA/DLP based 3D bio-printing methods and post-processing techniques
2+ years of experience working in a hands-on laboratory environment
2+ years of product development experience
1+ years of experience in change management
Strong initiative, collaboration, and organizational skills
Experience with biomaterial formulations and 3D printing processes and post processing operations
Proficient in statistical analysis (JMP, Excel, and/or Graph Pad Prism)
Ability to work independently and as part of a team
Preferred Qualifications
Master’s Degree in materials science, chemistry, chemical, mechanical or biomedical engineering (or related)
2+ years of manufacturing experience
2+ years of tech transfer experience in clinical or non-clinical manufacturing environments
Knowledge of quality control principles and methodology
Knowledge of GxP (GDP, GLP, and GMP)
Experience with biocompatibility and sterilization
Knowledge of perfusion bioreactors and general cell culture principles
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.
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