ProductLife Group
Overview
Join to apply for the
Senior/Principal CSV Consultant
role at
ProductLife Group . PLG is seeking a highly skilled professional to lead and support
Computerized System Validation (CSV)
and
Data Integrity (DI)
projects across regulated life sciences environments. This role involves hands-on execution, strategic consulting, and client-facing responsibilities, contributing to the deployment of digital quality solutions such as
eQMS ,
eValidation , and IT governance frameworks. The targeted base compensation range for this position is between $100k and $170k annually. Please note this is PLGUS’s good-faith and reasonable estimate of the range of possible compensation for this particular position at the time of posting; however, PLGUS may ultimately pay more or less than the posted range. Location: United States, with roles possibly in Boston, MA or Massachusetts-based offices depending on the assignment. Responsibilities
Lead or support validation projects, including planning, execution, and documentation of CSV deliverables. Conduct system testing, defect tracking, and resolution activities. Review and approve validation deliverables authored by junior team members. Collaborate with clients to gather requirements, assess compliance gaps, and define validation strategies. Support digital quality initiatives, including deployment of eQMS and eValidation solutions. Contribute to audit and inspection readiness by ensuring documentation quality and regulatory alignment. Provide mentoring and guidance to Associate-level consultants. Oversee development of IT governance SOPs and quality documentation. Design and lead Data Integrity programs, including risk identification and mitigation. Conduct project, system, and vendor audits. Support operational controls such as change control, configuration management, incident management, and CAPA. Required Qualifications
Education: Bachelor’s degree or higher in a relevant field (e.g., Life Sciences, IT, Quality). Experience: 2–5 years in Computerized System Validation (CSV), Data Integrity (DI), or IT Quality within a regulated life sciences environment. Regulatory Knowledge: Strong understanding of GxP, FDA 21 CFR Part 11, Annex 11, and other applicable regulations. Validation Expertise: Hands-on experience authoring and executing validation deliverables, including URS, FS, IQ, OQ, PQ; risk-based validation approaches (GAMP 5, ASTM E2500). Experience with validation of systems such as LIMS, CTMS, ERP, or eQMS platforms. Familiarity with systems across clinical, manufacturing, laboratory, supply chain, and pharmacovigilance environments. Experience with eValidation tools and digital quality platforms. Infrastructure Qualification: Familiarity with IT infrastructure qualification (e.g., cloud, SaaS, hosting environments). Lifecycle & Governance: Exposure to lifecycle risk management, supplier assessment, and periodic review processes. Experience with data integrity tools and techniques (e.g., GEMBA, gap analysis, data analytics). Understanding of additional regulatory frameworks (e.g., Data Privacy, Sarbanes-Oxley). Documentation Tools: Proficiency in Microsoft Office tools for documentation, reporting, and presentation. Domain Experience: Experience with regulated domains including GLP, GCP, GMP, GDP, GPvP. Other
Industries: Pharmaceutical Manufacturing and Biotechnology Research. Seniority level: Mid-Senior level. Employment type: Full-time. Job function: Consulting and Information Technology.
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Join to apply for the
Senior/Principal CSV Consultant
role at
ProductLife Group . PLG is seeking a highly skilled professional to lead and support
Computerized System Validation (CSV)
and
Data Integrity (DI)
projects across regulated life sciences environments. This role involves hands-on execution, strategic consulting, and client-facing responsibilities, contributing to the deployment of digital quality solutions such as
eQMS ,
eValidation , and IT governance frameworks. The targeted base compensation range for this position is between $100k and $170k annually. Please note this is PLGUS’s good-faith and reasonable estimate of the range of possible compensation for this particular position at the time of posting; however, PLGUS may ultimately pay more or less than the posted range. Location: United States, with roles possibly in Boston, MA or Massachusetts-based offices depending on the assignment. Responsibilities
Lead or support validation projects, including planning, execution, and documentation of CSV deliverables. Conduct system testing, defect tracking, and resolution activities. Review and approve validation deliverables authored by junior team members. Collaborate with clients to gather requirements, assess compliance gaps, and define validation strategies. Support digital quality initiatives, including deployment of eQMS and eValidation solutions. Contribute to audit and inspection readiness by ensuring documentation quality and regulatory alignment. Provide mentoring and guidance to Associate-level consultants. Oversee development of IT governance SOPs and quality documentation. Design and lead Data Integrity programs, including risk identification and mitigation. Conduct project, system, and vendor audits. Support operational controls such as change control, configuration management, incident management, and CAPA. Required Qualifications
Education: Bachelor’s degree or higher in a relevant field (e.g., Life Sciences, IT, Quality). Experience: 2–5 years in Computerized System Validation (CSV), Data Integrity (DI), or IT Quality within a regulated life sciences environment. Regulatory Knowledge: Strong understanding of GxP, FDA 21 CFR Part 11, Annex 11, and other applicable regulations. Validation Expertise: Hands-on experience authoring and executing validation deliverables, including URS, FS, IQ, OQ, PQ; risk-based validation approaches (GAMP 5, ASTM E2500). Experience with validation of systems such as LIMS, CTMS, ERP, or eQMS platforms. Familiarity with systems across clinical, manufacturing, laboratory, supply chain, and pharmacovigilance environments. Experience with eValidation tools and digital quality platforms. Infrastructure Qualification: Familiarity with IT infrastructure qualification (e.g., cloud, SaaS, hosting environments). Lifecycle & Governance: Exposure to lifecycle risk management, supplier assessment, and periodic review processes. Experience with data integrity tools and techniques (e.g., GEMBA, gap analysis, data analytics). Understanding of additional regulatory frameworks (e.g., Data Privacy, Sarbanes-Oxley). Documentation Tools: Proficiency in Microsoft Office tools for documentation, reporting, and presentation. Domain Experience: Experience with regulated domains including GLP, GCP, GMP, GDP, GPvP. Other
Industries: Pharmaceutical Manufacturing and Biotechnology Research. Seniority level: Mid-Senior level. Employment type: Full-time. Job function: Consulting and Information Technology.
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