Job Title: CSV/CSA Consultant – ValGenesis & BMRAM
Location: Hopkinton, MA
Duration: 6+ Months
Job Type: Contract
Industry: Pharmaceutical / Biotechnology / Cell & Gene Therapy
Our client, a leading pharmaceutical/biotechnology organization, is seeking an experienced CSV/CSA Consultant to support the qualification and validation of GMP computerized systems, laboratory systems, and analytical equipment.
The ideal candidate will have strong hands-on experience in Computer System Validation (CSV), Computer Software Assurance (CSA), ValGenesis, and BMRAM, along with a solid understanding of GAMP 5, 21 CFR Part 11, ALCOA+, Data Integrity, and risk-based validation methodologies.
This role will also support CQV activities for laboratory and advanced analytical equipment used in cell and gene therapy environments, including flow cytometers, automated cell counters, cell viability/characterization systems, and other GMP laboratory equipment.
Lead and support CSV, CSA, and CQV activities for GMP computerized systems, laboratory systems, and analytical equipment.
Develop, review, and execute validation documentation, including:
User Requirements Specifications (URS)
Configuration/Functional Specifications
Risk Assessments
Validation Plans
Test Protocols
Requirements Traceability Matrices (RTM)
IQ/OQ/PQ
Validation Summary Reports (VSR)
Provide hands-on support with ValGenesis and BMRAM.
Support higher-level Performance Qualification (PQ) activities for computerized systems and integrated laboratory equipment.
Review configuration specifications and traceability matrices to ensure requirements are appropriately documented, mapped, and tested.
Apply GAMP 5, 21 CFR Part 11, ALCOA+, Data Integrity, and risk-based validation/CSA principles.
Support the organization's transition from traditional CSV to risk-based Computer Software Assurance (CSA/RBV) methodologies.
Assess computerized system data management, interfaces, electronic data flows, audit trails, electronic records, and system access controls.
Support qualification and validation of analytical/laboratory equipment, including:
Flow Cytometers
Automated Cell Counters
Cell Viability and Characterization Systems
Other Cell & Gene Therapy Analytical Systems
Refrigerators and Freezers
Environmental Chambers
Centrifuges
Incubators
Support deviations, change controls, CAPA, and other quality activities associated with validated systems and equipment.
Collaborate with Quality, Engineering, IT, Laboratory, Manufacturing, and external vendors.
Support inspection readiness and provide validation documentation/evidence during regulatory or quality audits.
Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical field.
5+ years of experience in pharmaceutical, biotechnology, or other regulated GMP environments.
Strong hands-on Computer System Validation (CSV) experience.
Hands-on ValGenesis experience – Required.
Hands-on BMRAM experience – Required.
Strong knowledge of GAMP 5 and 21 CFR Part 11.
Strong understanding of ALCOA+, Data Integrity, and electronic records/electronic signatures.
Experience with risk-based validation and/or Computer Software Assurance (CSA).
Strong experience developing, reviewing, and executing URS, Risk Assessments, Configuration Specifications, Test Protocols, RTMs, IQ/OQ/PQ, and Validation Summary Reports.
Experience with higher-level Performance Qualification (PQ).
Experience reviewing Configuration Specifications and Requirements Traceability Matrices.
Experience with computerized system data management, interfaces, data flows, audit trails, and access controls.
Experience qualifying laboratory and analytical equipment in a GMP environment.
Experience in Cell & Gene Therapy manufacturing or QC laboratory environments.
Experience with flow cytometers, automated cell counters, cell viability/characterization systems, or similar analytical platforms.
Experience with complex laboratory instrument software and integrated computerized systems.
Experience supporting CSA/RBV implementation or transformation.
Experience with traditional GMP laboratory equipment qualification, including freezers, refrigerators, environmental chambers, centrifuges, and incubators.
Experience supporting regulatory inspections or inspection readiness.
Experience working with cross-functional teams including Quality, Engineering, IT, Laboratory, Manufacturing, and vendors.
Computer System Validation (CSV), Computer Software Assurance (CSA), ValGenesis, BMRAM, GMP, GAMP 5, 21 CFR Part 11, ALCOA+, Data Integrity, Risk-Based Validation, IQ/OQ/PQ, URS, Configuration Specifications, Risk Assessments, Requirements Traceability Matrix (RTM), Validation Summary Reports, Laboratory Equipment Qualification, CQV, Audit Trails, Electronic Records, Data Flows, System Interfaces
Cell & Gene Therapy, Flow Cytometry, Automated Cell Counters, Cell Viability, Analytical Equipment, QC Laboratory, Laboratory Instrument Software, CSA/RBV, Regulatory Inspection Readiness
Work Location: Hopkinton, MA
Contract Duration: 6+ Months
Work Arrangement: Onsite
