Katalyst CRO ยท 1 month ago
Lead Validation Engineer
Wilson, NC
Contract
Onsite
Lead/Staff
10+ years expKatalyst Healthcares & Life Sciences is seeking a Lead Validation Engineer to oversee commissioning and qualification activities for automation and process systems at a regulated manufacturing site. This leadership role involves ensuring validation strategies align with regulatory expectations while mentoring a team of validation professionals and coordinating with cross-functional stakeholders.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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