Katalyst CRO ยท 2 days ago
CSV Consultant
Framingham, MA
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is a company specializing in cloud-based enterprise systems, and they are seeking a CSV Consultant to validate and maintain these systems. The role involves ensuring compliance with regulatory standards and performing various validation tasks for pharmaceutical and biotechnology applications.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Validate and maintain cloud-based enterprise systems including Oracle Fusion Cloud ERP, serialization platforms (Tracelink, Antares), and electronic quality management systems
Implement and validate Electronic Batch Record (EBR) systems such as MasterControl
Support serialization system validation for end-to-end drug product shipping in compliance with DSCSA regulations
Validate data migrations and integrations between enterprise systems (Oracle, Cardinal Health, Azure)
Perform release impact assessments and testing for SaaS system updates
Drive Computer Software Assurance (CSA)-based validation approaches for cloud systems
Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and laboratory equipment
Conduct Configuration Specification Verifications and periodic reviews for Autoclaves, Bioreactors, HPLCs, and other critical systems
Qualify cell therapy and manufacturing equipment including controlled rate freezers, flow cytometers, and production systems
Support commissioning and qualification of facilities, utilities, and Building Automation Systems (Client)
Author and execute validation protocols including Validation Plans, URS, FRS, IQ/OQ/PQ, RTM, and Validation Summary Reports
Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA++ data integrity principles
Support change control management, deviations, and CAPA processes in GxP environments
Perform SOP mapping and business process documentation for system implementations
Maintain validation documentation in Electronic Document Management Systems (EDMS)
Support regulatory inspection readiness by ensuring validation documentation is audit-ready
Participate in internal and external audits, providing validation evidence and technical expertise
Conduct data integrity assessments and implement controls to maintain compliance
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field
5-8+ years of hands-on Computer Systems Validation experience in pharmaceutical, biotechnology, or medical device industries
Strong experience with Oracle Fusion Cloud ERP or similar enterprise ERP systems (SAP, Oracle E-Business Suite)
Hands-on experience with SaaS/cloud-based system validation and CSA approaches
Equipment qualification experience (autoclaves, bioreactors, HPLCs, manufacturing equipment)
Proficiency with electronic quality systems (MasterControl, Veeva Vault, TrackWise, ZenQMS)
Strong knowledge of GAMP 5, 21 CFR Part 11, GxP, and data integrity principles
Proven ability to author, review, and execute IQ/OQ/PQ protocols independently
Strong understanding of risk-based validation and Computer Software Assurance (CSA)
Experience with change control, deviation management, and CAPA processes
Excellent documentation skills and attention to detail
Strong communication and collaboration skills with cross-functional teams
Ability to manage multiple priorities in a fast-paced GMP environment
Preferred
Experience validating serialization systems (Tracelink, Antares) and DSCSA compliance highly preferred
LIMS validation experience (LabWare, LabVantage, Empower)
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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