Katalyst CRO · 2 days ago
Sr. Validation Engineer
Wilson, NC
Contract
Onsite
Senior Level
7+ years expKatalyst CRO is a company specializing in life sciences, and they are seeking a Senior Validation Engineer to lead and manage lifecycle activities for automation and process systems. The role involves collaborating with cross-functional teams to ensure validation deliverables meet project timelines and compliance with regulatory standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
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
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
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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