Instrument & Medical Device Validation Specialist chez Cognizant

%3Ch1%3EAbout the role%3Co:p%3E%3C/o:p%3E%3C/h1%3E%3Cp class=%22MsoNormal%22%3EAs an %3Cstrong%3EInstrument %26amp; Medical Device Validation Specialist%3C/strong%3E, you will make an impact by ensuring software installed on laboratory instruments meets regulatory standards and aligns with internal SOPs. You will be a valued member of the Quality %26amp; Compliance team and work collaboratively with cross-functional stakeholders including IT, QA, and lab operations to support a critical validation initiative.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Ch1%3EIn this role, you will:%3Co:p%3E%3C/o:p%3E%3C/h1%3E%3Cp class=%22MsoListBulletCxSpFirst%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EDocument and validate software installed on lab instruments in accordance with EMA regulatory guidelines.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpMiddle%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EMigrate instrument software management processes to align with PPD IT SOPs.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpMiddle%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3ECapture and document software requirements and configurations.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpMiddle%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EDevelop validation test cases and protocols for instruments and medical devices.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpMiddle%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3ECreate infrastructure and data flow diagrams to support validation efforts.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpMiddle%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EConduct comprehensive risk assessments.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpLast%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3ECollaborate with internal teams to ensure compliance and documentation accuracy.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Ch1%3EWork model:%3Co:p%3E%3C/o:p%3E%3C/h1%3E%3Cp class=%22MsoNormal%22%3EThis is an onsite position requiring presence at the client location in %3Cstrong%3EHighland Heights, Kentucky, USA%3C/strong%3E. At Cognizant, we strive to provide flexibility wherever possible, and we are here to support a healthy work-life balance through our various wellbeing programs.%3Cbr%3E%3Cbr%3EThe working arrangements for this role are accurate as of the date of posting. This may change based on the project you’re engaged in, as well as business and client requirements. Rest assured; we will always be clear about role expectations.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Ch1%3EWhat you need to have to be considered:%3Co:p%3E%3C/o:p%3E%3C/h1%3E%3Cp class=%22MsoListBulletCxSpFirst%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EExtensive experience in instrument or medical device validation within a regulated (GxP) environment.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpMiddle%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EStrong technical writing skills for documentation and test case development.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpMiddle%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EFamiliarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpMiddle%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EExperience with risk assessment methodologies and validation lifecycle documentation.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpMiddle%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EExcellent communication skills and ability to work with cross-functional teams.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpLast%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EHigh attention to detail with a focus on compliance and accuracy.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Ch1%3EThese will help you stand out:%3Co:p%3E%3C/o:p%3E%3C/h1%3E%3Cp class=%22MsoListBulletCxSpFirst%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EPrior experience in lab instrumentation software validation.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpLast%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EAbility to work independently and manage multiple validation tasks simultaneously.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Ch2%3E%3Cspan style=%22color:#365F91;font-size:14.0pt;%22%3E%3Cspan style=%22line-height:115%;mso-themecolor:accent1;mso-themeshade:191;%22%3EBenefits%3Co:p%3E%3C/o:p%3E%3C/span%3E%3C/span%3E%3C/h2%3E%3Cp class=%22MsoListBulletCxSpFirst%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EMedical/Dental/Vision/Life Insurance%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpMiddle%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EPaid holidays plus Paid Time Off%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpMiddle%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3E401(k) plan and contributions%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpMiddle%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3ELong-term/Short-term Disability%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpMiddle%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EPaid Parental Leave%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListBulletCxSpLast%22 style=%22margin-left:.25in;mso-add-space:auto;mso-list:l0 level1 lfo1;tab-stops:list .25in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;%22%3E%3Cspan style=%22mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;mso-bidi-font-family:Symbol;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EEmployee Stock Purchase Plan%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3EWe%27re excited to meet people who share our mission and can make an impact in a variety of ways. Don%27t hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.%3Co:p%3E%3C/o:p%3E%3Co:p%3E%3C/o:p%3E%3C/p%3E Postuler maintenant