"Alerted.org

About the role

**As an MES Validation Lead,** you will make an impact by driving Computer System Validation (CSV) initiatives within the Life Sciences domain, ensuring compliance with global regulatory standards. You will be a valued member of the Quality and Compliance team and work collaboratively with cross-functional stakeholders across QA, IT, and business units.

In this role, you will:

• Lead validation strategy and execution for Document Management Systems and manufacturing platforms.

• Oversee interoperability validation to ensure seamless integration across enterprise systems.

• Coordinate CSV activities in alignment with FDA, EMA, MHRA, and other global regulatory requirements.

• Develop and manage validation documentation including URS, Risk Assessments, IQ/OQ/PQ, Traceability Matrix, and Summary Reports.

• Mentor junior team members and foster a culture of continuous improvement and audit readiness.

Work model:

Hybrid

We believe hybrid work is the way forward as we strive to provide flexibility wherever possible. Based on this role’s business requirements, this is a hybrid position requiring 3 days a week in a client or Cognizant office in Boston, MA. 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:

• Deep knowledge of GxP regulations and global compliance standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5).

• Proven expertise in validation lifecycle management including authoring and reviewing validation plans and traceability matrices.

• Strong experience in Life Sciences manufacturing systems such as OPM, Informatica, Veeva QMS & DMS, ARVETO 3PL, Oracle Transportation, Global Trade Management, Oracle EBS.

• Ability to lead cross-functional teams and manage validation deliverables across geographies.

• Proficiency in tools like HP ALM, JIRA, ServiceNow, and SharePoint.

These will help you stand out:

• Experience in risk-based validation, deviation handling, CAPA management, and process harmonization.

• Familiarity with Agile, Waterfall, and V-Model SDLC methodologies.

• Strong documentation skills and audit readiness for internal and external inspections.

• Excellent communication and stakeholder engagement capabilities.

• A proactive approach to problem-solving and continuous learning.

Salary and Other Compensation:

The annual salary for this position is between $71,100 - $112,500 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

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.

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.