Validation Analyst

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 is a leading consulting and services firm specializing in providing comprehensive technology solutions for Life Sciences IT organizations. Our primary focus is on assisting these organizations in effectively and efficiently delivering solutions that support their business objectives and their mission to enhance human health and improve lives.

Summary

We are seeking a Validation Analyst with a passion for the Life Sciences sector. In this role, you will assist in the validation and qualification of various computerized systems, ensuring compliance with GxP regulations. This is an excellent opportunity to gain experience in CSV (Computer System Validation) while working on cutting-edge projects in the pharmaceutical, biotechnology, or healthcare industries.

Key Responsibilities:

• Support the validation lifecycle for systems, including planning, testing, execution, and Validation Life cycle.
• Perform risk assessments and gap analyses to ensure that all systems are compliant with industry standards such as 21 CFR Part 11, GAMP5, and Annex 11.
• Collaborate with cross-functional teams to ensure validation efforts 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 issues during validation and ensure adherence to SDLC (Software Development Life Cycle).
• Keep updated with industry regulations and emerging trends in validation and compliance.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• 2+ years of experience in validation or quality assurance, preferably within a GxP-regulated environment.
• Basic knowledge of CSV principles, including validation protocol creation and execution.
• Familiarity with regulatory standards such as FDA 21 CFR Part 11, GAMP5, and Annex 11.
• Experience with SDLC, change control, and risk management processes.
• Strong analytical and problem-solving skills.
• Excellent communication skills and attention to detail.

Preferred Skills:

• Experience in eQMS or ERP system validation (e.g., Veeva, LabVantage, or SAP).
• Understanding of process validation in pharmaceutical manufacturing.
• Hands-on experience with risk-based validation approaches.

We offer an excellent compensation and benefits package with challenge and opportunity to learn, grow, and contribute to a stimulating, fast-paced environment. Osprey Life Sciences is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status, or any other characteristic protected by law.