Senior CSV/ITQ Validation Lead

Osprey Life Sciences

Indiana (PA)

On-site

USD 120,000 - 160,000

Full time

3 days ago

Be an early applicant

Application generator

A complete application in a minute — tailored resume and cover letter, ready to send.

Get past ATS filters

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.