Katalyst CRO ยท 1 month ago
Computer System Validation Engineer
Princeton, NJ
Contract
Onsite
Entry, Mid Level
2+ years expKatalyst CRO is seeking a Computer System Validation Engineer to ensure compliance with regulatory requirements through effective validation of computer systems. The role involves planning, coordinating, and executing validation activities while collaborating with IT, Quality Assurance, and business stakeholders.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Knowledge on FDA Guidance's and industry Standards
Develop and execute validation plans, protocols (IQ/OQ/PQ), and reports for computer systems
Assess and document system requirements, risk assessments, and user requirements specifications (URS)
Review and approve system design, configuration, and test documentation
Ensure compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, GAMP 5, EU Annex 11)
Manage change control and deviation management processes for validated systems
Collaborate with cross-functional teams (IT, QA, business users) to ensure validation deliverables are met
Maintain validation documentation and support periodic reviews and revalidation
Participate in internal and external audits and respond to regulatory inquiries
Train users and stakeholders on validated systems and compliance requirements
Stay current with industry trends, regulations, and best practices in computer system validation
Qualification
Required
Knowledge on FDA Guidance's and industry Standards
Develop and execute validation plans, protocols (IQ/OQ/PQ), and reports for computer systems
Assess and document system requirements, risk assessments, and user requirements specifications (URS)
Review and approve system design, configuration, and test documentation
Ensure compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, GAMP 5, EU Annex 11)
Manage change control and deviation management processes for validated systems
Collaborate with cross-functional teams (IT, QA, business users) to ensure validation deliverables are met
Maintain validation documentation and support periodic reviews and revalidation
Participate in internal and external audits and respond to regulatory inquiries
Train users and stakeholders on validated systems and compliance requirements
Stay current with industry trends, regulations, and best practices in computer system validation
Bachelor's degree in Computer Science, Life Sciences, Engineering, or related field
2+ years of experience in computer system validation or a regulated industry
Knowledge of applicable regulations (FDA, EMA, GxP, 21 CFR Part 11, Annex 11)
Experience with validation methodologies (GAMP 5, risk-based validation)
Strong documentation, analytical, and problem-solving skills
Excellent communication and teamwork abilities
Preferred
Experience with ERP, LIMS, MES, or other regulated systems is a plus
Familiarity with project management tools and methodologies
Experience with audit preparation and participation
Understanding of data integrity principles
Certification in validation or quality assurance (e.g., ASQ, ISPE) is a plus
Prior work experience in Medical Device Industry, Biotechnology or Pharmaceutical industry is a plus
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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