Job Details

Key Responsibilities

• Support development of the validation strategy and validation plan for the JMP implementation, in alignment with the client's computer system validation (CSV) or Computer Software Assurance (CSA) methodology. 

• Author and execute validation deliverables, including user requirements specifications (URS), functional/design specifications, risk assessments, and traceability matrices. 

• Develop and execute test scripts covering installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) as applicable. 

• Document and manage deviations, discrepancies, and test failures through resolution, including root cause analysis and corrective actions. 

• Support configuration verification of JMP, including add-ins, scripts, and integrations with other systems (e.g., LIMS, data repositories) where applicable. 

• Prepare and maintain validation summary reports and ensure all documentation meets GxP and 21 CFR Part 11 requirements. 

• Collaborate with IT and system administrators to verify installation, security configuration, and access controls. 

• Support change control activities for the validated system, including impact assessments for patches, upgrades, or configuration changes. 

• Assist in preparing the system and documentation for internal and external audits/inspections. 

• Communicate validation status, risks, and timelines to the project lead and client stakeholders. 

Required Qualifications

• 2–5 years of experience in computer system validation within the life sciences, pharmaceutical, biotech, or medical device industry. 

• Hands-on experience authoring and executing validation protocols (IQ/OQ/PQ) and related documentation. 

• Familiarity with JMP or other statistical/data analysis software (e.g., SAS, Minitab) . 

• Working knowledge of GxP requirements, 21 CFR Part 11, and data integrity principles (e.g., ALCOA+). 

• Experience with computer system validation (CSV) and/or Computer Software Assurance (CSA) methodologies. 

• Strong technical writing skills, with the ability to produce clear, audit-ready documentation. 

• Comfortable working directly with client stakeholders in a consulting environment. 

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Preferred Qualifications

• Direct experience validating JMP or similar statistical analysis tools in a regulated environment. 

• Familiarity with risk-based validation approaches and quality risk management (e.g., ICH Q9). 

• Bachelor's degree in a relevant field (life sciences, engineering, statistics, computer science, or related discipline). 

Success in the Role
The successful candidate will independently execute assigned validation activities, produce high-quality validation documentation, identify issues early, and work effectively with client Engineering, Quality, Operations, Facilities, and IT organizations.

Work Authorization
Qualified applicants must be authorized to work in the United States on a full-time basis. HbSage will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.