Job Details
Validation Test Lead - Lab Instrumentation / Medical Devices
**About the role**
As a **Validation Test Lead - Lab Instrumentation / Medical Devices** , you will make an impact by ensuring regulatory compliance and validation of software used in medical laboratory instrumentation. You will be a valued member of the quality and compliance team and work collaboratively with cross-functional stakeholders, including regulatory affairs, engineering, and client teams.
**In this role, you will:**
- Lead the development and execution of validation and testing strategies for regulated software systems
- Document and validate instrument software in accordance with EMA guidelines and GxP requirements
- Perform risk assessments and proactively communicate risks to stakeholders
- Develop validation test cases, software specifications, and supporting documentation (including infrastructure and data flow diagrams)
- Collaborate with cross-functional teams to ensure seamless integration of compliance requirements
**Work model**
We strive to provide flexibility wherever possible. Based on this role's business requirements, this is a **remote position open to qualified applicants within the United States** . Regardless of your working arrangement, 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**
- Proven **lead-level experience** in lab instrumentation or medical device software validation within a regulated (GxP) environment
- Strong knowledge of **EMA guidelines, validation lifecycle, and compliance standards**
- Expertise in **technical documentation, validation test case creation, and specification writing**
- Experience conducting **risk assessments and validation lifecycle documentation**
- Strong communication and stakeholder management skills across cross-functional teams
**These will help you stand out**
- Experience in **pharmaceutical or medical device industry environments**
- Familiarity with **IT SOPs and regulatory audit readiness**
- Proven ability to **lead teams and mentor members in validation best practices**
- Experience driving **process improvements in testing frameworks and tools**
- Exposure to a **utomation or innovative testing approaches in regulated environments**
**Salary and Other Compensation:**
Applications will be accepted until June 22, 2026.
The annual salary for this position is between $83,250- $131,500 depending on experience and other qualifications of the successful candidate.
This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.
**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***
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
As a **Validation Test Lead - Lab Instrumentation / Medical Devices** , you will make an impact by ensuring regulatory compliance and validation of software used in medical laboratory instrumentation. You will be a valued member of the quality and compliance team and work collaboratively with cross-functional stakeholders, including regulatory affairs, engineering, and client teams.
**In this role, you will:**
- Lead the development and execution of validation and testing strategies for regulated software systems
- Document and validate instrument software in accordance with EMA guidelines and GxP requirements
- Perform risk assessments and proactively communicate risks to stakeholders
- Develop validation test cases, software specifications, and supporting documentation (including infrastructure and data flow diagrams)
- Collaborate with cross-functional teams to ensure seamless integration of compliance requirements
**Work model**
We strive to provide flexibility wherever possible. Based on this role's business requirements, this is a **remote position open to qualified applicants within the United States** . Regardless of your working arrangement, 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**
- Proven **lead-level experience** in lab instrumentation or medical device software validation within a regulated (GxP) environment
- Strong knowledge of **EMA guidelines, validation lifecycle, and compliance standards**
- Expertise in **technical documentation, validation test case creation, and specification writing**
- Experience conducting **risk assessments and validation lifecycle documentation**
- Strong communication and stakeholder management skills across cross-functional teams
**These will help you stand out**
- Experience in **pharmaceutical or medical device industry environments**
- Familiarity with **IT SOPs and regulatory audit readiness**
- Proven ability to **lead teams and mentor members in validation best practices**
- Experience driving **process improvements in testing frameworks and tools**
- Exposure to a **utomation or innovative testing approaches in regulated environments**
**Salary and Other Compensation:**
Applications will be accepted until June 22, 2026.
The annual salary for this position is between $83,250- $131,500 depending on experience and other qualifications of the successful candidate.
This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.
**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***
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Job #NLX293201562