Software Validation Senior Associate
Listed on 2026-08-08
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Pharmaceutical
Regulatory Compliance Specialist, Validation Engineer
Software Validation Senior Associate
Are you an experienced Computerized Systems Validation (CSV) professional with a passion for quality, compliance, and project leadership? We're seeking a Software Validation Senior Associate to support our GxP laboratories by leading software validation initiatives that ensure regulatory compliance, system reliability, and operational excellence.
In this highly visible role, you'll manage the complete software validation lifecycle while partnering with laboratory operations, Quality, IT, and system owners to validate computerized systems supporting pharmaceutical and biotechnology research and development.
If you're looking for an opportunity to combine technical expertise, project management, and regulatory compliance in a collaborative, science-driven environment, we'd love to hear from you.
As a Software Validation Senior Associate, you'll lead and support Computerized Systems Validation (CSV) projects from initiation through completion while ensuring compliance with FDA, GAMP, ICH, and global regulatory expectations.
Key responsibilities include:
- Leading the full Computerized Systems Validation (CSV) lifecycle for GxP laboratory software and computerized systems.
- Developing validation strategies, validation plans, risk assessments, protocols, reports, and supporting documentation.
- Authoring and executing Software Development Life Cycle (SDLC) documentation including:
- User Requirements Specifications (URS)
- Functional and Design Specifications
- Risk Assessments
- Traceability Matrices
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Partnering with system owners and cross-functional teams to develop compliant validation documentation and implementation plans.
- Defining project scope, timelines, milestones, deliverables, and resource requirements for CSV initiatives.
- Tracking project progress, facilitating status meetings, and providing regular updates to leadership.
- Supporting software implementations, upgrades, system enhancements, and change controls while ensuring continued GxP compliance.
- Reviewing existing validation documentation, identifying compliance gaps, and executing remediation plans.
- Authoring and maintaining Quality System documentation including SOPs, Change Controls, CAPAs, and validation procedures.
- Serving as a subject matter expert during internal and external regulatory inspections.
- Monitoring evolving FDA, GAMP, ICH, USP, and global regulatory requirements to maintain an effective validation program.
What we're looking for includes:
- Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related technical discipline (or equivalent experience).
- Minimum of 3 years of Computerized Systems Validation (CSV) experience within pharmaceutical, biotechnology, CRO, or other regulated GxP environments.
- Hands-on experience developing, executing, and documenting validation protocols and software qualification activities.
- Strong project management experience leading multiple validation initiatives simultaneously.
- Experience preparing and maintaining SDLC validation documentation including URS, Functional Specifications, Design Specifications, Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrices, and Validation Reports.
- Working knowledge of ERP, laboratory software, and computerized systems used in regulated environments.
- Excellent technical writing, documentation, and communication skills.
- Strong organizational, analytical, and problem-solving abilities.
- Experience supporting FDA, client, or international regulatory inspections.
- Experience validating laboratory systems, analytical instruments, LIMS, CDS, ELN, or other GxP computerized systems.
- Knowledge of software implementation, system upgrades, and change management processes.
Why Pharmaron?
Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small…
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