Senior Validation Specialist or Engineer, Manufacturing Equipment - United Therapeutics
Silver Spring, MD
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 Validation Specialist or Engineer, Equipment will perform activities independently in support of equipment qualification for the manufacturing and quality control laboratory teams, including developing and reviewing protocols and final reports, representing validation on project teams, and preparing validation change control requests and assessments. This role will also support developing validation plans, requirements, specifications, protocols, and final reports, as needed.
+ Work independently to apply extensive knowledge and skills to contribute at a high level with a full understanding of equipment validation
+ Coordinate validation activities, serve as the validation subject matter expert in specific areas of equipment validation and may serve as the primary validation person in validation projects for the manufacturing and quality control laboratories teams
+ Develop and execute protocols and summarize reports supporting the validation of equipment, systems, and processes, as needed. Participate in the preparation or review of protocols and reports from junior peers and provide input as necessary
+ Collect, compile, analyze, and review data in support of validation activities. Analyze and interpret data and information through more sophisticated or in-depth analysis to confirm the validated state of the equipment for GMP use with some or minimal supervision.
+ Develop, execute, and review various types of validation lifecycle documentation, including but not limited to: SOPs, Master Plans, User Requirement and Functional Requirements Specifications, Design Specifications, Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and Design Qualification (DQ), IQ, OQ, PQ, PV protocols and reports. Provide execution and documentation oversight of junior team members
+ Troubleshoot and resolve a wide range of complex issues including, but not limited to: equipment, computer, or process-related, where precedent may not exist, referring only the most complex issues to higher-level staff
+ Work independently on problems of diverse scope where analysis of data requires identification of root cause events. Select methods and techniques for problem-solving and decision-making
+ Perform gap analysis of validation documentation, systems, and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements
+ Provide technical guidance and training to other team members in various aspects of validation. Provide training to company and contracted personnel on validation policies and procedures
+ Provide general support to the validation organization to meet department goals and objectives
+ Support change control activities from a validation perspective in order to generate change assessments
+ Participate in internal and regulatory agency audits to provide validation expertise
+ Perform other duties as assigned
For this role you will need
Minimum Requirements
+ For the _Senior Validation Specialist_ level: Bachelor’s Degree in a scientific field and 5+ years of relevant validation experience in a pharmaceutical/cGMP environment
+ For the _Senior Validation Engineer_ level : Bachelor’s Degree in an _engineering_ field and 5+ years of relevant validation experience in a pharmaceutical/cGMP environment
+ Ability to effectively communicate, both written and orally, with colleagues and management cross-functionally, to provide the status of validation activities, to collaborate with peers, senior colleagues, and internal partners, and to present data or information within the broader department or cross-functional areas
+ Detail oriented, self-motivated, and organized with the ability to prioritize work
+ Ability to easily adapt to change
+ Ability to work with minimal supervision on assigned tasks and projects
+ Working knowledge of validation datalogger software (Amphenol/Ellab preferred)
+ Working knowledge of regulatory requirements from the USFDA and EU related to validation activity
+ Working knowledge of word processing, spreadsheets, basic statistical software, and email software
+ Working knowledge of target systems, including computerized information systems, manufacturing control systems (e.g., PLC, BMS, DCS, and SCADA systems), and laboratory automation systems (e.g., robotic systems, chromatography networks, data acquisition systems)
+ Ability to perform, review, and oversee process and cleaning qualification for processes that may include Solid Dose, API, Fill Finish, and packaging
+ Utilize skill as an experienced validation professional with a full understanding of industry practices and company policies and procedures
Preferred Qualifications
+ For the _Senior Validation, Engineer_ level: Working knowledge of target systems, including computerized information systems, manufacturing control systems (e.g., PLC, BMS, DCS, and SCADA systems), and laboratory automation systems (e.g., robotic systems, chromatography networks, data acquisition systems)
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 Validation Specialist or Engineer, Equipment will perform activities independently in support of equipment qualification for the manufacturing and quality control laboratory teams, including developing and reviewing protocols and final reports, representing validation on project teams, and preparing validation change control requests and assessments. This role will also support developing validation plans, requirements, specifications, protocols, and final reports, as needed.
+ Work independently to apply extensive knowledge and skills to contribute at a high level with a full understanding of equipment validation
+ Coordinate validation activities, serve as the validation subject matter expert in specific areas of equipment validation and may serve as the primary validation person in validation projects for the manufacturing and quality control laboratories teams
+ Develop and execute protocols and summarize reports supporting the validation of equipment, systems, and processes, as needed. Participate in the preparation or review of protocols and reports from junior peers and provide input as necessary
+ Collect, compile, analyze, and review data in support of validation activities. Analyze and interpret data and information through more sophisticated or in-depth analysis to confirm the validated state of the equipment for GMP use with some or minimal supervision.
+ Develop, execute, and review various types of validation lifecycle documentation, including but not limited to: SOPs, Master Plans, User Requirement and Functional Requirements Specifications, Design Specifications, Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and Design Qualification (DQ), IQ, OQ, PQ, PV protocols and reports. Provide execution and documentation oversight of junior team members
+ Troubleshoot and resolve a wide range of complex issues including, but not limited to: equipment, computer, or process-related, where precedent may not exist, referring only the most complex issues to higher-level staff
+ Work independently on problems of diverse scope where analysis of data requires identification of root cause events. Select methods and techniques for problem-solving and decision-making
+ Perform gap analysis of validation documentation, systems, and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements
+ Provide technical guidance and training to other team members in various aspects of validation. Provide training to company and contracted personnel on validation policies and procedures
+ Provide general support to the validation organization to meet department goals and objectives
+ Support change control activities from a validation perspective in order to generate change assessments
+ Participate in internal and regulatory agency audits to provide validation expertise
+ Perform other duties as assigned
For this role you will need
Minimum Requirements
+ For the _Senior Validation Specialist_ level: Bachelor’s Degree in a scientific field and 5+ years of relevant validation experience in a pharmaceutical/cGMP environment
+ For the _Senior Validation Engineer_ level : Bachelor’s Degree in an _engineering_ field and 5+ years of relevant validation experience in a pharmaceutical/cGMP environment
+ Ability to effectively communicate, both written and orally, with colleagues and management cross-functionally, to provide the status of validation activities, to collaborate with peers, senior colleagues, and internal partners, and to present data or information within the broader department or cross-functional areas
+ Detail oriented, self-motivated, and organized with the ability to prioritize work
+ Ability to easily adapt to change
+ Ability to work with minimal supervision on assigned tasks and projects
+ Working knowledge of validation datalogger software (Amphenol/Ellab preferred)
+ Working knowledge of regulatory requirements from the USFDA and EU related to validation activity
+ Working knowledge of word processing, spreadsheets, basic statistical software, and email software
+ Working knowledge of target systems, including computerized information systems, manufacturing control systems (e.g., PLC, BMS, DCS, and SCADA systems), and laboratory automation systems (e.g., robotic systems, chromatography networks, data acquisition systems)
+ Ability to perform, review, and oversee process and cleaning qualification for processes that may include Solid Dose, API, Fill Finish, and packaging
+ Utilize skill as an experienced validation professional with a full understanding of industry practices and company policies and procedures
Preferred Qualifications
+ For the _Senior Validation, Engineer_ level: Working knowledge of target systems, including computerized information systems, manufacturing control systems (e.g., PLC, BMS, DCS, and SCADA systems), and laboratory automation systems (e.g., robotic systems, chromatography networks, data acquisition systems)
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