🤖 15+ AI Agents working for you. Find jobs, score and update resumes, cover letter, interview questions, missing keywords, and lots more.
Cookies & analytics consent
We serve candidates globally, so we only activate Google Tag Manager and other analytics after you opt in. This keeps us aligned with GDPR/UK DPA, ePrivacy, LGPD, and similar rules. Essential features still run without analytics cookies.
Read how we use data in our Privacy Policy and Terms of Service.
🤖 15+ AI Agents working for you. Find jobs, score and update resumes, cover letter, interview questions, missing keywords, and lots more.
American Unit, Inc • Wilson, North Carolina, United States
Role & seniority: Lead Validation Engineer / Architect (senior/lead level)
Stack/tools: Kneat, GVault (validation tools); familiarity with cGMP, FDA, EU regulatory standards
Lead planning, execution, and documentation of C&Q lifecycle (URS, DQ, IQ, OQ, PQ) for automation and process systems
Develop and implement validation strategies aligned with quality standards and regulatory requirements
Serve as primary validation lead across engineering, QA, manufacturing, and automation; review/approve protocols and reports
10+ years in validation within pharmaceutical/biotech regulated environments
Experience leading large-scale C&Q projects; greenfield/brownfield familiarity
PMP or equivalent project management certification
Bachelor’s or Master’s in Engineering, Life Sciences, or related field
Deep regulatory knowledge (FDA, EU, cGMP) and industry best practices
Strong communication, organizational, and stakeholder management
Proficiency with Kneat, GVault or equivalent validation tools
Nice-to-haves: (not specified in the source)
Location & work type: Wilson, NC; onsite; long-term; OT 10 hours/week
Lead Validation Engineer / Architect Wilson, NC – Onsite Long term OT - 10 hours per week
Top 3 Must Have's: Life science Domain, Validation Skills, Delta V & MES Validation
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.
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.
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.