Lead Validation Engineer

Wilson, NC, US • Posted 60+ days ago • Updated 36 minutes ago

Full Time

On-site

Fitment

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Job Details

Skills

URS
IQ
OQ
PQ
Quality Assurance
Manufacturing
Resource Allocation
Risk Management
IT Management
Mentorship
Auditing
Presentations
Documentation
Regulatory Compliance
Good Manufacturing Practice
Pharmaceutics
Leadership
Management
Communication
Stakeholder Management
PMP
Project Management
Life Sciences
MES

Summary

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.

Roles and 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.

Education:

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.
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.
Life science Domain, Validation Skills, Delta V & MES Validation.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 3023e913cf6c25a28fe427bcd4f1468a
Posted 30+ days ago

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Lead Validation Engineer

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Job Details

Skills

Summary

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