Validation Engineer

Osprey Life Sciences; Indiana (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

Osprey Life Sciences, LLC is a leading Life Sciences IT consulting firm seeking a Senior Validation Analyst / Senior CSV ITQ to own validation deliverables across multiple projects. You will lead hands-on validation activities in GxP environments and ensure inspection-ready systems throughout the lifecycle.

Responsibilities include risk assessments, SDLC coordination, and cross-functional collaboration with QA, IT, and vendors.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• 6+ years of hands-on Computer System Validation experience within Life Sciences industries.
• Strong understanding of GxP regulations and computerized system compliance.
• Familiarity with 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.

Responsibilities

• Lead validation efforts across projects, including planning, testing, and lifecycle execution.
• Perform risk assessments and gap analyses for regulatory compliance.
• Collaborate with QA, IT, and stakeholders to meet timelines and quality standards.
• Maintain documentation for regulatory audits and inspections.
• Participate in reviews of validated systems to ensure ongoing compliance.
• Coordinate change control related to system updates or modifications.
• Troubleshoot validation issues in collaboration with IT and QA teams.
• Stay updated on industry regulations and validation trends.

Skills

Analytical thinking

Problem solving

Communication skills

Attention to detail

Regulatory knowledge

Education

Bachelor's degree in Life Sciences or Engineering

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 an experienced Senior Validation Analyst / Senior CSV ITQ (Computer System Validation - IT Quality) professional to lead hands-on validation and qualification of computerized systems in GxP-regulated Life Sciences environments. This is an individual contributor role responsible for independently owning CSV/ITQ deliverables across multiple projects and ensuring compliant, inspection-ready systems throughout the computerized system lifecycle.

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.
• 6+ years of hands-on Computer System Validation experience within Pharmaceutical, Biotechnology, Medical Device, or Life Sciences industries.
• Strong understanding of GxP regulations and computerized system compliance.
• 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.

• Assess system changes and determine validation impact.
• Act as ITQ/CSV lead for multiple projects simultaneously as a hands-on individual contributor.
• Collaborate with QA, IT, Infrastructure, Security, Business Owners, and Vendors.
• Provide project timelines, status updates, validation metrics, risks, issues, and action items to stakeholders.

Regulatory Knowledge

• FDA 21 CFR Part 11; EU Annex 11; GAMP 5; Data Integrity Guidelines; ALCOA+ principles; Good Documentation Practices (GDP).

Technical Skills

• Validation lifecycle management; risk-based validation; change control; SDLC methodologies; cloud validation (AWS, Azure, SaaS); electronic records/electronic signatures compliance; test management tools and documentation systems.

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.