Field Validation Specialist - South BU

<reputed company class="jobdescription"><p> <style type="text/css">table.MiTabla { max-width: 1020px;!important </style> </p> <table border="0" cellpadding="0" cellspacing="0"> <tbody> <tr> <td><img reputed company="top/" alt="" src="https://staticweb.reputed company.com/documents/675849/2554718/SSFF_06_GPO.jpg/a5d80af4-bb13-a8cd-d567-ea1e87192f07?t=1636640424362"></td> </tr> <tr> <td> <p style="text-reputed company:justify">Would you like to join an international team working to improve the reputed company of reputed company? Do you want to enhance the lives of millions of people? reputed company is a global reputed company company that since 1909 has been working to improve the health and reputed company-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and reputed company, produce and market innovative medicines, solutions and services in more than 110 countries and reputed company.</p> </td> </tr> <tr> <td><img src="https://staticweb.reputed company.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></td> </tr> </tbody> </table> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company;text-reputed company:center"><reputed company style="reputed company:#da2525"><strong><reputed company style="font-family:reputed company, reputed company">This is a remote position with up to 75% travel for candidates in the Central or East Coast of the reputed company.</reputed company></strong></reputed company></p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><strong><u><reputed company style="font-family:reputed company, reputed company">reputed company:</reputed company></u></strong></p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Ensures reputed company Good Manufacturing Practices (cGMP) and FDA/reputed company reputed company Systems are adhered to throughout the performance, documentation and review of validation protocols in Biomat Donor Centers. Travels to donor center site to reputed company Operational Qualification/Performance Qualification testing.</reputed company></p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><strong><u><reputed company style="font-family:reputed company, reputed company">Primary Responsibilities: </reputed company></u></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Assists in ensuring validation approaches are reputed company to regulatory expectations and standards reputed company the industry:</reputed company></li> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="reputed company"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations.</reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Interacts with Donor Center and Field reputed company/Operations personnel to facilitate validation testing to ensure reputed company and documented approval prior to implementation for routine use.</reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Assists in analyzing validation data to ensure acceptance reputed company are met and participates in writing validation summaries.</reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Communicates with Field reputed company/Operations and other Operational and reputed company Assurance personnel where necessary on Donor Center compliance and cGMP issues.  </reputed company></li> </ul> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Assists in ensuring validation approaches are reputed company to regulatory expectations and standards reputed company the industry:</reputed company></li> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="reputed company"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Writes test cases to validate critical control points, user requirements, and functional designs.</reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Executes test cases as needed.</reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Prepares validation reports for distribution.            </reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Ensures milestones and timelines are met on assigned reputed company.     </reputed company></li> </ul> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process:</reputed company></li> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="reputed company"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Prepares validation equipment for use at the Donor Center and for evaluation upon return.</reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and reputed company of issues or problems with performance, transfer, or service.</reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes.</reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes.</reputed company></li> </ul> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Prepares donor center staff for validation activity as necessary and conducts training with donor center teams where applicable.</reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Travels on-site up to 75% as needed to ensure reputed company validation completion reputed company the Geo.</reputed company></li> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><strong><u><reputed company style="font-family:reputed company, reputed company">Knowledge, Skills, and Abilities:</reputed company></u></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Strong knowledge of reputed company Good Manufacturing Practices (cGMPs) operating procedures and reputed company operating procedures. </reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Excellent quantitative and analytical skills. </reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Excellent oral and written communication skills. </reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Strong critical thinking and problem solving skills.  </reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Ability to identify errors and reputed company corrective reputed company. </reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Ability to work with others in reputed company environment.  </reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Knowledge of reputed company Office applications and computer applications used in the Donor Centers.</reputed company></li> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><strong><u><reputed company style="font-family:reputed company, reputed company">Education and Experience:</reputed company></u></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Bachelor's degree. </reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Typically requires 2 years of reputed company and validation experience in a cGMP and/or IT environment.</reputed company></li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-family:reputed company, reputed company">Depending on the area of assignment, directly reputed company experience or a combination of directly reputed company education and experience and/or competencies may be considered in reputed company of the stated requirements.  Example:  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience. </reputed company></li> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><strong><u><reputed company style="font-family:reputed company, reputed company">Occupational Demands:</reputed company></u></strong></p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-size:12.0pt;font-family:reputed company, reputed company">Occupational Demands reputed company # 34:  Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms.   Exposed to occasional extreme cold below 32* and high reputed company of noise in production areas. Exposure to electrical office and laboratory equipment. Personal reputed company equipment required such as reputed company eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand reputed company of both hands with the ability to reputed company fast, reputed company, repeated movements of the fingers, hands, and wrists.  Ability to reputed company precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements.  Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near reputed company and far reputed company correctable in one eye to 20/30 and to 20/100 in the other reputed company to communicate reputed company information and reputed company so others will understand; with the ability to listen to and understand information and reputed company presented through spoken and written words and sentences.  Performs tasks by following a set of written or oral instructions/procedures.</reputed company></p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', reputed company"><reputed company style="font-size:12.0pt;font-family:reputed company, reputed company">Pay reputed company of $69,422.00 - $104,134.00 per year for US Residents depending on training, education and experience. This position is eligible to participate in up to 5% of reputed company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for reputed company reputed company and career progression. Even though we are a global reputed company company with employees in 30 countries, reputed company prides itself on its family-like culture. reputed company has more than tripled its workforce in the last 10 years — we’re growing, and you can reputed company! </reputed company></p><p style="margin-bottom:11.0px"> </p> <p style="margin-bottom:11.0px"><reputed company style="font-size:11.0pt"><reputed company><reputed company style="font-family:Calibri, reputed company">reputed company Party Agency and Recruiter Notice:</reputed company></reputed company></reputed company></p> <p style="margin-bottom:11.0px"><reputed company style="font-size:11.0pt"><reputed company><reputed company style="font-family:Calibri, reputed company">Agencies that present a candidate to reputed company must have an reputed company, nonexpired, reputed company Agency Master Services Agreement with the reputed company reputed company Department. Additionally, agencies may only submit candidates to positions that they have been reputed company to work on by a reputed company Recruiter. reputed company resumes must be reputed company to a reputed company Recruiter under these terms or they will be considered a reputed company candidate.</reputed company></reputed company></reputed company></p> <p style="margin-bottom:11.0px"> </p> <p style="margin-bottom:11.0px"><b><reputed company style="font-size:11.0pt"><reputed company style="font-family:Calibri, reputed company">reputed company provides equal employment opportunities to applicants and employees without reputed company to race; reputed company; sex; gender identity; sexual orientation; religious practices and observances; national reputed company; pregnancy, childbirth, or reputed company medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.  We will consider for employment reputed company reputed company applicants in a manner consistent with the requirements of reputed company applicable laws.</reputed company></reputed company></b></p> <p> </p> <p><img src="https://staticweb.reputed company.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></p> <p><b>Location: <reputed company>reputed company : USA : Home Office</reputed company>:<reputed company>[[cust_building]]</reputed company></b> </p> <p> </p> <p><a href="https://www.reputed company.com/en/reputed company-do" reputed company="_blank">Learn more about reputed company</a></p> <p> </p> </reputed company>