Jobs for People with MS: National MS Society

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 Lead Validation Engineer, performs both functional/technical expertise and leadership activities that support validation activities for organ manufacturing capital projects and operations that includes Xenotransplantation and regenerative medicines operations. This includes developing and advising on content and approach for building and system requirements, specifications, protocols and final reports in accordance with FDA and appropriate international regulations/guidelines and latest industry practices. This role will act as the validation expert on project teams to provide guidance and leadership. The Lead Validation Engineer oversees and performs simultaneous activities for multiple projects. This can include developing validation strategy and requirements, active project participation, performing validation assessments, and developing change plans for change control activities.

• Independently handle, troubleshoot and resolve the most complex issues and problems, whether equipment, computer, or process-related, where precedent may not exist. Work independently in selecting methods and techniques and evaluation criteria for problem-solving and decision-making.

• Directly oversee the strategic hiring of 3rd party validation resources to directly support projects. Directly create requests for proposals and summary of qualifications for all validation hiring decisions on projects.

• Provide validation planning (both short-term and long-term) to support the diagnosis of validation problems (both internal and external), implement corrective and preventive actions to resolve those problems, and support continuous improvement of validation programs

• Provide specialized technical expertise with equipment validations for the manufacturing and quality control laboratory teams, considering the relative value of several alternative solutions to potential issues before confirming a final decision as to the path forward

• Analyze and integrate data and information from multiple streams in support of validation activities. Analyze and interpret data and information through more sophisticated or in-depth analysis, reaching conclusions based on complex data sets to confirm the validated state of the equipment for GMP use with some oversight or guidance.

• Develop, execute, and/or review various types of validation documentation, including but not limited to: SOPs, Validation 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 summarizes reports. Participate in the preparation or review of protocols and reports for junior peers and provide input as necessary.

• Provide technical and strategic guidance and training to other team members in various aspects of validation, data analysis, sampling techniques and other traditional areas of validation expertise. Provide training to company and contracted personnel on validation policies and procedures.

• Lead multiple and more complex projects, programs, initiatives and activities to support the goals and objectives of the Validation department under limited supervision

• Act as the validation contact on project teams requiring validation support

• Initiate, support, and approve change controls from a validation perspective in order to generate change assessments

• Participate in internal and regulatory agency audits to provide validation expertise

• Manage and supervise validation contractors and teams

• Perform other duties as assigned

For this role you will need

Minimum Requirements

• Bachelor’s Degree in an engineering field

• 8+ years of relevant validation experience in a pharmaceutical/cGMP environment

• Proficient knowledge of US and international regulations related to validation activity

• Experience with Validation Datalogger Software (preferably Amphenol / Ellab)

• Ability to perform validation activities for equipment, process and/or computer-related validation protocols

• Ability to support test execution by either overseeing or else providing hands-on assistance during testing to either System Owners or Validation management

• Ability to interact and communicate with System Owners as the Validation Functional expert

• Use skills as an experienced professional with a full understanding of industry practices, company policies, company procedures, and guidance

• Ability to lead simultaneous activities requiring collaboration with internal and external groups to deliver validation projects, department initiatives, and periodic reviews on time and within budget

• Ability to provide feedback and recommendations to validation management regarding department work practices, procedures, and guidance

• Ability to anticipate project needs, potential gaps, and pitfalls through forecasting and estimations, which are based on prior experience

• Highly organized, detail-oriented, self-motivated, and communicative regarding prioritization and forecasting of project activities

• Strong leadership and interpersonal interactions with peers or other employees to provide training, coaching, and guidance

• Ability to give and receive collaborative feedback in a professional manner

• Ability to communicate effectively, both written and orally, with internal leaders and key customers as a lead (sub) function expert

• Working knowledge of these software applications: TrackWise, Master Control, Regulatory Asset Manager

• Ability to independently work with minimal supervision on assigned tasks and projects

• Proficient with Microsoft Office and email software

• Must not have interaction with pigs outside of the company

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.