Senior Process Engineer, Print Operations - United Therapeutics
Manchester, NH
About the Job
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
The job details are as follows:
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.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
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
Minimum Requirements
+ 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.
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_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._
The job details are as follows:
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.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
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
Minimum Requirements
+ 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.
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_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._
Source : United Therapeutics