Position OverviewWe are seeking a detail-oriented and experienced
Validation Specialist to join our growing team. In this role, you will be instrumental in ensuring that our computerized systems and software meet rigorous regulatory compliance, data integrity, and quality standards.
If you have a strong background in Computer Systems Validation (CSV), IT infrastructure compliance, and quality management-particularly within regulated or laboratory environments-we want to hear from you.
Key Responsibilities- Computer Systems Validation (CSV): Manage multiple site and global CSV projects from inception to completion. Create validation deliverables, develop execution templates, and perform comprehensive CSV risk assessments.
- Quality Management: Own change records, CAPAs (Corrective and Preventive Actions), and quality events for CSV projects. Serve as a subject matter expert during internal and external site audits and inspections.
- IT Compliance & Infrastructure Support: Partner with laboratory operations to ensure all computer systems feature up-to-date antivirus software, active backups, and supported operating systems. Perform monthly patching and auditing risk assessments.
- Inventory & Asset Oversight: Maintain accurate software and hardware inventories for scientific and enterprise applications across GMP and non-GMP environments.
- Metrics & Reporting: Deliver routine status reports on projects, SOP updates, audit observations, and compliance metrics to stakeholders.
Qualifications & Requirements- Education: Bachelor's Degree in Information Technology, Computer Science, or a related technical field.
- Experience: Minimum of 3 years of hands-on experience in quality assurance, computer systems validation (CSV), and/or information technology.
- Preferred Background: Direct experience working within the pharmaceutical, biotech, medical device, or highly regulated laboratory operations sector.
- Technical Fluency: Strong understanding of data integrity principles, compliance frameworks (such as 21 CFR Part 11 / Annex 11), SOP generation, and system risk management.
For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
Additional Skills(none specified)
AllSTEM Representative Contact InfoAccount Executive: IN HOUSE
Branch Phone: (909) 244-1777
Location: Houston, TX
