Job Summary
Lead MES Validation - The Lead MES Syncade Validation Engineer leads the validation strategy and execution for Syncade MES and related systems in a GxP-regulated life science manufacturing environment. The role ensures electronic batch records recipes and integrations are validated per GAMP 5 21 CFR Part 11 and EU Annex 11 while mentoring the validation team and maintaining inspection-ready compliance and data integrity.
Responsibilities
- Lead the validation strategy planning and execution for Syncade MES projects upgrades and site rollouts using a risk-based GAMP 5 approach
- Author and review validation deliverables including validation plans URS FS/DS risk assessments IQ/OQ/PQ protocols traceability matrices and summary reports
- Oversee testing of Syncade EBRs master recipes workflows and integrations with DeltaV ERP (e.g. SAP) LIMS and historians
- Ensure compliance with 21 CFR Part 11 EU Annex 11 and data integrity (ALCOA+) requirements including audit trails and electronic signatures
- Manage change controls deviations CAPAs and impact assessments to keep systems in a validated state throughout the lifecycle
- Provide technical leadership mentoring and work direction to validation engineers testers and contractors
- Collaborate with QA Manufacturing IT Automation and vendors to align requirements resolve test failures and approve deliverables
- Define and maintain validation SOPs templates and standards and drive adoption of global validation practices across sites
- Support periodic reviews internal audits and regulatory inspections as the subject matter expert for Syncade validation
- Identify opportunities to streamline validation through automation reusable test scripts and computer software assurance (CSA) principles
About Cognizant:
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, bridging the gap between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, drive tangible outcomes and keep global enterprises ahead in a fast-changing world. See how at cognizant.ai or @cognizant.
Additional employment information
Compensation 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.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
