Senior/Lead Validation Engineer – Commissioning & Qualification (C&Q)

Cognizant Technology Solutions Corporation; Wilson (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading global consulting firm in Wilson, NC is seeking a Senior Validation Engineer to oversee and drive commissioning and qualification (C&Q) activities. The ideal candidate will have extensive experience in validation, strong leadership skills, and proficiency with validation tools. This onsite position offers competitive benefits including insurance, paid time off, and a 401(k) plan.

Benefits

Medical/Dental/Vision/Life Insurance

Paid holidays plus Paid Time Off

401(k) plan

Long-term/Short-term Disability

Paid Parental Leave

Employee Stock Purchase Plan

Qualifications

• 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.

Responsibilities

• Lead the planning, execution, and documentation of C&Q lifecycle activities.
• Develop and implement validation strategies in alignment with quality standards.
• Serve as the primary point of contact for validation-related matters.

Skills

Leadership

Communication

Stakeholder management

Regulatory requirements knowledge

Validation tools proficiency

Education

Bachelor’s or Master’s degree in Engineering or Life Sciences

Tools

Kneat

GVault

Job description

Senior/Lead Validation Engineer – Commissioning & Qualification (C&Q)

3 days ago Be among the first 25 applicants

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.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Quality Assurance

Industries

IT Services and IT Consulting and Business Consulting and Services