Job Details

Key Responsibilities​

Computerized Systems Validation 

• Support CSV/CSA activities for regulated computerized systems. 

• Develop and/or execute validation documentation including: 

• User Requirements Specifications 

• Functional/Design Specifications 

• Risk Assessments 

• Test Protocols 

• Traceability Matrices 

• Validation Reports 

• Execute system testing and document results. 

• Support assessment and resolution of deviations and defects. 

• Apply data integrity and GxP principles to computerized system validation. 

 

Validation Documentation 

• Prepare, review, and execute validation protocols. 

• Develop validation plans and support documentation. 

• Analyze qualification and validation data. 

• Prepare validation reports and summary documentation. 

• Maintain validation records in accordance with document control requirements. 

• Ensure traceability between requirements, testing, results, and conclusions. 

 

Quality & Compliance 

• Ensure validation activities are performed in accordance with approved procedures and protocols. 

• Apply GMP/GxP, data integrity, and applicable regulatory expectations. 

• Participate in deviation, change control, and CAPA activities related to validation. 

• Support internal and external audits by providing validation documentation and technical support. 

• Identify validation gaps and recommend appropriate remediation.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or related technical discipline. 

• 3–6 years of relevant validation, qualification, or commissioning experience in the life sciences industry. 

• Hands-on experience with computerized system validation. 

• Working knowledge of IQ/OQ/PQ principles. 

• Experience developing and executing validation protocols. 

• Strong technical writing and documentation skills. 

• Ability to interpret technical drawings, specifications, and system documentation. 

• Working knowledge of GMP/GxP requirements. 

• Strong analytical and problem-solving skills. 

• Ability to work independently at client sites. 

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Preferred Qualifications

• Experience in pharmaceutical, biotechnology, cell therapy, gene therapy, medical device, or other regulated environments. 

• Experience with Computer System Validation or Computer Software Assurance 

• Experience with electronic validation systems. 

• Familiarity with risk-based validation methodologies. 

• Familiarity with cGMP regulations, Good Engineering Practices (GEP), ISPE guidance, and GAMP 5. 

• Experience supporting regulatory or customer audits. 

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.