Lead Validation Engineer Architect Wilson, NC
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Job Location:
Wilson, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
Role: Lead Validation Engineer / Architect
Location: Wilson NC Onsite
Duration: Long term
Top 3 Must Haves: Life science Domain Validation Skills Delta V & MES Validation
Job Summary:
- The 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 Skills:
- 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
- Bachelors or Masters 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.
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
