Ecocareers · 22 hours ago
Sr. Validation Engineer
Wilson, NC
Full-time
Onsite
Senior Level
7+ years expEcocareers is a company focused on life sciences, and they are seeking a Senior Validation Engineer to lead and manage C&Q lifecycle activities. The role involves collaborating with cross-functional teams, developing validation protocols, and providing technical guidance to junior engineers.
Staffing & Recruiting
Responsibilities
Lead and manage C&Q lifecycle activities including URS, DQ, IQ, OQ, and PQ for automation and process systems
Collaborate with cross-functional teams including engineering, QA, manufacturing, and automation to ensure validation deliverables align with project timelines
Develop and review validation protocols, reports, and supporting documentation in compliance with FDA, EU standards
Utilize tools such as Kneat, GVault, or equivalent systems for document control and validation tracking
Provide technical guidance and mentorship to junior validation engineers and contractors
Support change control processes and deviation investigations related to validated systems
Participate in audits and inspections, providing subject matter expertise on validation practices and documentation
Ensure alignment with the overall execution and resource plan as outlined in the C&Q strategy
Qualification
Required
Life science Domain
Validation Skills
Delta V & MES Validation
Bachelor's or master's degree in engineering, Life Sciences, or related field
Minimum 7+ years of experience in validation within the pharmaceutical or biotech industry
Strong knowledge of cGMP, FDA, ICH, and EU regulations
Proven experience with commissioning and qualification of automation systems
Proficiency in validation tools such as Kneat, GVault, or similar platforms
Excellent communication, documentation, and project coordination skills
Experience working on large-scale C&Q projects in a regulated environment
Preferred
Familiarity with systems and validation practices is a plus
PMP or equivalent project management certification
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase