Validation Specialist - Medical Devices & Instruments at Cognizant - Thailand

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Full Time

Start Date

Immediate

Expiry Date

14 Jan, 26

Salary

0.0

Posted On

16 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation, Medical Devices, Technical Writing, Risk Assessment, Compliance, Documentation, Cross-functional Collaboration, Attention to Detail, Software Requirements, Test Case Development, Regulatory Standards, SOPs, Data Flow Diagrams, Validation Protocols, GxP Environment, Instrument Software

Industry

IT Services and IT Consulting

Description

About the role As an Validation Specialist – Medical Devices & Instruments, 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 & Compliance team and work collaboratively with cross-functional stakeholders including IT, QA, and lab operations to support a critical validation initiative. In this role, you will: · Document and validate software installed on lab instruments in accordance with EMA regulatory guidelines. · Migrate instrument software management processes to align with PPD IT SOPs. · Capture and document software requirements and configurations. · Develop validation test cases and protocols for instruments and medical devices. · Create infrastructure and data flow diagrams to support validation efforts. · Conduct comprehensive risk assessments. · Collaborate with internal teams to ensure compliance and documentation accuracy. Work model: This is an onsite position requiring presence at the client location in Highland Heights, Kentucky, USA. 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. 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: · 8+ years of extensive experience in instrument or medical device validation within a regulated (GxP) environment. · Strong technical writing skills for documentation and test case development. · Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings. · Experience with risk assessment methodologies and validation lifecycle documentation. · Excellent communication skills and ability to work with cross-functional teams. · High attention to detail with a focus on compliance and accuracy. These will help you stand out: · Prior experience in lab instrumentation software validation. · Ability to work independently and manage multiple validation tasks simultaneously. Benefits · 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 We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't 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.

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Responsibilities

The Validation Specialist will ensure that software installed on laboratory instruments meets regulatory standards and aligns with internal SOPs. This role involves documenting and validating software, developing test cases, and collaborating with cross-functional teams to support validation initiatives.