Validation Engineer or Specialist II, Equipment - United Therapeutics
Research Triangle Park, NC
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.
*Must have an engineering degree to have the engineering title*
How you’ll contribute
The _Validation Engineer or Specialist II, Equipment_ will perform activities in support of equipment qualification including developing and reviewing protocols and final reports, representing Validation on project teams, and assisting in preparing Validation change control requests and assessments. This role can be hired at the Senior level with more experience.
+ Work under general supervision to apply broadening and developing validation expertise, skills, experience, and knowledge at the professional level to apply a solid working knowledge of equipment validation to resolve moderately complex issues and consults with higher-level staff for more complex issues
+ Develop and execute protocols and summarize reports supporting validation of equipment, computer systems and processes
+ Collect, compile and analyze validation data and information with some or minimal supervision, demonstrating ownership of data to confirm the validated state of the equipment for GMP use
+ Participate on project teams requiring validation support to represent the function internally on specific projects
+ Exercises judgment within generally defined procedures and practices to determine appropriate action or to recommend alternative solutions
+ Communicate effectively, both written and orally, with colleagues and management cross-functionally, to provide the status of validation activities. Collaborate with peers and senior colleagues
+ Contribute to the Validation organization to ensure department goals and objectives are met. Contributions may include leading small initiatives with limited resource requirements, and/or complexity
+ Support change control activities from a validation perspective in order to meet department goals and objectives
+ Revise validation SOPs and lifecycle validation documentation
+ Perform equipment and other validation related requalifications and periodic reviews with general supervision
+ Perform other duties as assigned
For this role you will need
Minimum Requirements
+ Validation Engineer II, Equipment requires a Bachelor’s degree in an engineering field and 2+ years of relevant validation experience in a pharmaceutical/cGMP environment [can be hired at Senior Validation Engineer, Equipment with 5+ years of experience]
+ Validation Specialist II, Equipment requires Bachelor’s degree in a scientific field and 2+ years of relevant validation experience in a pharmaceutical/cGMP environment [can be hired at Senior Validation Specialist, Equipment with 5+ years of experience]
+ Working knowledge of Microsoft Office and email software
+ Detail-oriented, self-motivated, organized, and have the ability to prioritize work
+ Ability to communicate effectively, both written and orally with colleagues, management and senior management - cross-functionally
+ Easily adapts to change
+ Ability to influence and may provide guidance to junior or support team members.
+ Ability to work with minimal supervision
+ Working knowledge of validation datalogger software (Amphenol/Ellab) use to perform temperature/humidity mapping.
+ Working knowledge of TrackWise or comparable quality systems and/or electronic document management systems
+ Working knowledge of regulatory requirements from the US FDA and EU
+ Ability to communicate with regulatory agencies, when applicable
+ Ability to qualify Solid Dose, API, Fill Finish, and/or Packaging processing equipment
Preferred Qualifications
+ Ability to quality analytical equipment that may include HPLC, UPLC, Spectrophotometers, LAL Readers, TOC Analyzers
+ Ability to qualify processing equipment that may include Autoclaves, Isolators, Bioreactors, Tanks, Depyrogenation Tunnel, Blow Fill Seal, Fluid Bed Granulator, Tablet Press, Tablet Coaters, Packaging Lines
+ Ability to quality utilities that may include Purified Water Systems, Compressed Air System, Nitrogen, HVAC, WFI System
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.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_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.
*Must have an engineering degree to have the engineering title*
How you’ll contribute
The _Validation Engineer or Specialist II, Equipment_ will perform activities in support of equipment qualification including developing and reviewing protocols and final reports, representing Validation on project teams, and assisting in preparing Validation change control requests and assessments. This role can be hired at the Senior level with more experience.
+ Work under general supervision to apply broadening and developing validation expertise, skills, experience, and knowledge at the professional level to apply a solid working knowledge of equipment validation to resolve moderately complex issues and consults with higher-level staff for more complex issues
+ Develop and execute protocols and summarize reports supporting validation of equipment, computer systems and processes
+ Collect, compile and analyze validation data and information with some or minimal supervision, demonstrating ownership of data to confirm the validated state of the equipment for GMP use
+ Participate on project teams requiring validation support to represent the function internally on specific projects
+ Exercises judgment within generally defined procedures and practices to determine appropriate action or to recommend alternative solutions
+ Communicate effectively, both written and orally, with colleagues and management cross-functionally, to provide the status of validation activities. Collaborate with peers and senior colleagues
+ Contribute to the Validation organization to ensure department goals and objectives are met. Contributions may include leading small initiatives with limited resource requirements, and/or complexity
+ Support change control activities from a validation perspective in order to meet department goals and objectives
+ Revise validation SOPs and lifecycle validation documentation
+ Perform equipment and other validation related requalifications and periodic reviews with general supervision
+ Perform other duties as assigned
For this role you will need
Minimum Requirements
+ Validation Engineer II, Equipment requires a Bachelor’s degree in an engineering field and 2+ years of relevant validation experience in a pharmaceutical/cGMP environment [can be hired at Senior Validation Engineer, Equipment with 5+ years of experience]
+ Validation Specialist II, Equipment requires Bachelor’s degree in a scientific field and 2+ years of relevant validation experience in a pharmaceutical/cGMP environment [can be hired at Senior Validation Specialist, Equipment with 5+ years of experience]
+ Working knowledge of Microsoft Office and email software
+ Detail-oriented, self-motivated, organized, and have the ability to prioritize work
+ Ability to communicate effectively, both written and orally with colleagues, management and senior management - cross-functionally
+ Easily adapts to change
+ Ability to influence and may provide guidance to junior or support team members.
+ Ability to work with minimal supervision
+ Working knowledge of validation datalogger software (Amphenol/Ellab) use to perform temperature/humidity mapping.
+ Working knowledge of TrackWise or comparable quality systems and/or electronic document management systems
+ Working knowledge of regulatory requirements from the US FDA and EU
+ Ability to communicate with regulatory agencies, when applicable
+ Ability to qualify Solid Dose, API, Fill Finish, and/or Packaging processing equipment
Preferred Qualifications
+ Ability to quality analytical equipment that may include HPLC, UPLC, Spectrophotometers, LAL Readers, TOC Analyzers
+ Ability to qualify processing equipment that may include Autoclaves, Isolators, Bioreactors, Tanks, Depyrogenation Tunnel, Blow Fill Seal, Fluid Bed Granulator, Tablet Press, Tablet Coaters, Packaging Lines
+ Ability to quality utilities that may include Purified Water Systems, Compressed Air System, Nitrogen, HVAC, WFI System
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.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_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
