Instrument/Medical Device Validation Specialist at Cognizant

%3Cp class=%22MsoNormal%22%3E%3Cstrong%3EAbout the role%3C/strong%3E%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3EAs an%26nbsp;%3Cstrong%3EInstrument/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%26nbsp;Quality Engineering and Assurance Team, collaborating closely with IT, QA, and lab operations to support a critical compliance initiative.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3E%3Cstrong%3EIn this role, you will:%3C/strong%3E%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cul style=%22margin-top:0in;%22 type=%22disc%22%3E%3Cli class=%22MsoNormal%22 style=%22mso-list:l2 level1 lfo1;tab-stops:list .5in;%22%3EValidate software installed on lab instruments in accordance with EMA regulatory guidelines.%3Co:p%3E%3C/o:p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22mso-list:l2 level1 lfo1;tab-stops:list .5in;%22%3EMigrate instrument software management processes to align with PPD IT SOPs.%3Co:p%3E%3C/o:p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22mso-list:l2 level1 lfo1;tab-stops:list .5in;%22%3ECapture and document software requirements, configurations, and infrastructure.%3Co:p%3E%3C/o:p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22mso-list:l2 level1 lfo1;tab-stops:list .5in;%22%3EDevelop validation test cases, protocols, and risk assessments for lab instrumentation.%3Co:p%3E%3C/o:p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22mso-list:l2 level1 lfo1;tab-stops:list .5in;%22%3ECreate infrastructure and data flow diagrams to support validation efforts.%3Co:p%3E%3C/o:p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22mso-list:l2 level1 lfo1;tab-stops:list .5in;%22%3EConduct comprehensive risk assessments.%3Co:p%3E%3C/o:p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22mso-list:l2 level1 lfo1;tab-stops:list .5in;%22%3ECollaborate with cross-functional teams to ensure documentation accuracy and compliance.%3Co:p%3E%3C/o:p%3E%3C/li%3E%3C/ul%3E%3Cp class=%22MsoNormal%22%3E%3Cstrong%3EWork model%3C/strong%3E%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3EAt Cognizant, we strive to provide flexibility wherever possible, and we are here to support a healthy work-life balance though our various wellbeing programs. Based on this role’s business requirements, this is an %3Cstrong%3Eonsite position%3C/strong%3E requiring 5 days a week in a client or Cognizant office in Highland Heights, Kentucky, USA%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNormal%22%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%3Cp class=%22MsoNormal%22%3E%3Cstrong%3EWhat you need to have to be considered%3C/strong%3E%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cul style=%22margin-top:0in;%22 type=%22disc%22%3E%3Cli class=%22MsoNormal%22 style=%22mso-list:l1 level1 lfo2;tab-stops:list .5in;%22%3E6–10+ years of experience in Instrument/Medical Device validation within a regulated (GxP) environment.%3Co:p%3E%3C/o:p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22mso-list:l1 level1 lfo2;tab-stops:list .5in;%22%3EStrong technical writing skills for documentation and test case development.%3Co:p%3E%3C/o:p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22mso-list:l1 level1 lfo2;tab-stops:list .5in;%22%3EFamiliarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings.%3Co:p%3E%3C/o:p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22mso-list:l1 level1 lfo2;tab-stops:list .5in;%22%3EExperience with risk assessment methodologies and validation lifecycle documentation.%3Co:p%3E%3C/o:p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22mso-list:l1 level1 lfo2;tab-stops:list .5in;%22%3EExcellent communication skills and attention to detail.%3Co:p%3E%3C/o:p%3E%3C/li%3E%3C/ul%3E%3Cp class=%22MsoNormal%22%3E%3Cstrong%3EThese will help you stand out%3C/strong%3E%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cul style=%22margin-top:0in;%22 type=%22disc%22%3E%3Cli class=%22MsoNormal%22 style=%22mso-list:l0 level1 lfo3;tab-stops:list .5in;%22%3EPrior experience in lab instrumentation software validation.%3Co:p%3E%3C/o:p%3E%3C/li%3E%3C/ul%3E%3Cp class=%22MsoListParagraphCxSpFirst%22 style=%22mso-list:l0 level1 lfo3;tab-stops:list .5in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;font-size:10.0pt;%22%3E%3Cspan style=%22line-height:115%;mso-bidi-font-family:Symbol;mso-bidi-font-size:12.0pt;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;line-height:115%;mso-bidi-font-family:Symbol;mso-bidi-font-size:12.0pt;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 as part of a team in a fast-paced environment.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListParagraphCxSpMiddle%22 style=%22mso-list:l0 level1 lfo3;tab-stops:list .5in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;font-size:10.0pt;%22%3E%3Cspan style=%22line-height:115%;mso-bidi-font-family:Symbol;mso-bidi-font-size:12.0pt;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;line-height:115%;mso-bidi-font-family:Symbol;mso-bidi-font-size:12.0pt;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3EExcellent communication and collaboration skills.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoListParagraphCxSpLast%22 style=%22mso-list:l0 level1 lfo3;tab-stops:list .5in;text-indent:-.25in;%22%3E%3Cspan style=%22font-family:Symbol;font-size:10.0pt;%22%3E%3Cspan style=%22line-height:115%;mso-bidi-font-family:Symbol;mso-bidi-font-size:12.0pt;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E·%3C/span%3E%3Cspan style=%22font:7.0pt %26quot;Times New Roman%26quot;;line-height:115%;mso-bidi-font-family:Symbol;mso-bidi-font-size:12.0pt;mso-fareast-font-family:Symbol;mso-list:Ignore;%22%3E%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp;%26nbsp; %3C/span%3E%3C/span%3ECognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship%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%3C/p%3E%3Cp class=%22MsoNormal%22%3E%3Co:p%3E %3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3E%3Cstrong%3ESalary and Other Compensation:%3Co:p%3E%3C/o:p%3E%3C/strong%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3EApplications will be accepted until October 30%3Csup%3Eth%3C/sup%3E, 2025%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3EThe annual salary for this position is between %2453,477 to 92,500 depending on experience and other qualifications of the successful candidate.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3EThis position is also eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3E%26nbsp;%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3EBenefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNoSpacing%22%3EMedical/Dental/Vision/Life Insurance%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNoSpacing%22%3EPaid holidays plus Paid Time Off%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNoSpacing%22%3E401(k) plan and contributions%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNoSpacing%22%3ELong-term/Short-term Disability%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNoSpacing%22%3EPaid Parental Leave%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNoSpacing%22%3EEmployee Stock Purchase Plan%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNoSpacing%22%3E%3Co:p%3E %3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3EDisclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.%3Co:p%3E%3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3E%3Co:p%3E %3C/o:p%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3E%3Cspan style=%22mso-ansi-language:ES-SV;%22 lang=%22ES-SV%22%3E%3Co:p%3E %3C/o:p%3E%3C/span%3E%3C/p%3E Apply Now