About the role
As a Validation Engineer – Lab Instrumentation/Medical Devices, you will make an impact by ensuring laboratory instrumentation software is validated and compliant with regulatory standards, contributing to high-quality and audit-ready systems. You will be a valued member of the validation team and work collaboratively with IT, Quality Assurance, and laboratory operations stakeholders to drive compliance and operational excellence.
In this role, you will:
• Validate and document software installed on laboratory instruments in accordance with EMA regulatory standards
• Migrate instrument software management processes to align with PPD IT SOPs
• Capture, document, and maintain software requirements and configurations
• Develop and execute validation test cases, protocols, and lifecycle documentation for instruments and medical devices
• Perform risk assessments and create infrastructure and data flow diagrams while collaborating with cross-functional teams
Work model: Onsite
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. Based on this role’s business requirements, this is an onsite position requiring presence in a client or Cognizant office in Highland Heights, Kentucky, USA.
The 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.
What you need to have to be considered
• 6+ years of experience in instrument or medical device validation within a regulated (GxP) environment
• Strong knowledge of validation lifecycle, including test case development and execution
• Proven experience working with EMA guidelines and IT SOPs in pharmaceutical or medical device settings
• Expertise in risk assessment methodologies and compliance-focused documentation
• Strong communication and technical writing skills, with the ability to collaborate across cross-functional teams
These will help you stand out
• Prior experience in laboratory instrumentation software validation
• Experience creating infrastructure and data flow diagrams
• Hands-on experience aligning validation processes with enterprise IT frameworks
• High attention to detail with a strong focus on compliance and accuracy
• Ability to work effectively in complex, cross-functional project environments
Benefits:
Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
Medical/Dental/Vision/Life Insurance
Paid holidays plus Paid Time Off
401(k) plan and contributions
Long-term/Short-term Disability
Paid Parental Leave
Employee Stock Purchase Plan
Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship.
*Please note, this role is not able to offer visa transfer or sponsorship now or in the future*
私たちについて：
コグニザント（NASDAQ: CTSH）は、AI builderおよびテクノロジーサービスプロバイダとして、AI投資を企業価値へとつなげるフルスタックのAIソリューションを提供しています。業界、業務プロセス、エンジニアリングに関する深い専門性を強みに、各企業固有のコンテキストをテクノロジーシステムに組み込み、人の力を最大限に引き出すとともに、具体的な成果の創出と、急速に変化する世界におけるグローバル企業の競争力維持を支援します。詳しくは、当社ウェブサイト www.cognizant.com をご覧ください。
雇用に関する追加情報
本募集に記載されている報酬情報は、掲載日時点で正確なものです。Cognizantは、適用される法令に従い、いつでも本情報を変更する権利を留保します。
応募者は、対面またはビデオ会議による面接への参加を求められる場合があります。また、各面接の際に、現在有効な州政府または政府発行の身分証明書の提示を求められる場合があります。
Cognizantは機会均等雇用主です。応募および選考において、人種、肌の色、性別、宗教、信条、性的指向、性自認、国籍、障がい、遺伝情報、妊娠、退役軍人の地位、その他連邦法・州法・地方自治体の法律により保護されるいかなる特性に基づく差別も行いません。
