Job Description

**Job Summary:** The Sr/Lead Validation Engineer will oversee and drive commissioning and qualification (C&Q) activities for automation and process systems at a regulated manufacturing site. This leadership role is responsible for ensuring validation strategies align with regulatory expectations and project goals, while mentoring a team of validation professionals and coordinating with cross-functional stakeholders. **Key Responsibilities:** + Lead the planning, execution, and documentation of C&Q lifecycle activities (URS, DQ, IQ, OQ, PQ) for automation and process systems. + Develop and implement validation strategies in alignment with quality standards and global regulatory requirements. + Serve as the primary point of contact for validation-related matters across engineering, QA, manufacturing, and automation teams. + Review and approve validation protocols, reports, and supporting documentation. + Manage validation timelines, resource allocation, and risk mitigation plans. + Provide technical leadership and mentorship to validation engineers and contractors. + Support audits and inspections by presenting validation documentation and processes. + Ensure compliance with cGMP, FDA, EU, and internal quality standards. **Required Qualifications:** + Bachelor's or Master's degree in Engineering, Life Sciences, or related field. + 10+ years of experience in validation within the pharmaceutical or biotech industry. + Demonstrated leadership in managing C&Q projects and teams. + Deep understanding of regulatory requirements and industry best practices. + Proficiency with validation tools such as Kneat, GVault, or equivalent. + Strong communication, organizational, and stakeholder management skills. **Preferred Qualifications:** + Experience with large-scale C&Q projects in regulated environments. + PMP or equivalent project management certification. + Prior experience leading validation efforts in greenfield or brownfield projects. **Working arrangements:** Based on this role's business requirements, this is an onsite position based out at Wilson NC. Note: 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. **Work Authorization:** Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship. **Salary and Other Compensation:** The annual salary for this position is depending on experience and other qualifications of the successful candidate. **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 Disclaimer: The salary, other compensation, and benefits 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. 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 Tags

Temporary work, For contractors,

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