Life Sciences CSV Validation Specialist

Osprey Life Sciences; Massachusetts; On-site; USD 60,000 - 90,000; Full time

Job summary

Osprey Life Sciences, LLC in Massachusetts seeks a Validation Analyst to support the validation and qualification of computerized systems, ensuring GxP compliance and CSV practices. You will help prepare validation plans, protocols, and execution documentation.

The role requires 2+ years in validation or QA, knowledge of 21 CFR Part 11 and related standards, and collaboration with IT and QA teams to maintain audit-ready records and support inspections.

Qualifications

• Bachelor's degree and 2+ years in validation or QA in a GxP-regulated environment.
• Knowledge of CSV principles including validation protocol creation and execution.
• Familiar with FDA 21 CFR Part 11, GAMP5, and Annex 11.

Responsibilities

• Support the validation lifecycle for systems, including planning, testing, execution, and Validation Life cycle.
• Perform risk assessments and gap analyses to ensure systems are compliant with industry standards.
• Collaborate with cross-functional teams to meet project timelines and quality standards.
• Maintain detailed documentation to support regulatory audits and inspections.
• Participate in periodic reviews of validated systems to ensure continued compliance.
• Help manage change control processes related to system updates or modifications.
• Coordinate with IT and quality teams to troubleshoot validation issues and ensure SDLC adherence.
• Keep updated with industry regulations and emerging trends in validation and compliance.

Skills

GxP compliance

Validation lifecycle

Regulatory standards

Analytical thinking

Communication skills

Attention to detail

Risk management

Education

Bachelor's degree in Life Sciences, Engineering, or related field

Tools

Veeva

LabVantage

SAP

Job description

Osprey Life Sciences, LLC in Massachusetts seeks a Validation Analyst to support the validation and qualification of computerized systems, ensuring GxP compliance and CSV practices. You will help prepare validation plans, protocols, and execution documentation.

The role requires 2+ years in validation or QA, knowledge of 21 CFR Part 11 and related standards, and collaboration with IT and QA teams to maintain audit-ready records and support inspections.