BSA III - Validation Analyst

Milestone Technologies, Inc. is hiring a BSA III - Validation Analyst for a 12‑month W2 contract in Thousand Oaks, CA. The role is onsite five days a week.

Compensation:
Up to $50/hr (USD $45‑$50/hr). No PTO or paid holidays.

• Lead and support GMP validations including IQ/OQ for laboratory instrument control systems and related software; manage multiple simultaneous validations (≈5 projects) and system requalification due to server migrations and Windows OS upgrades.
• Plan, execute, and validate upgrades of lab IT assets from Windows 10 to Windows 11; configure and deploy Windows‑based lab systems using predefined images; collaborate with scientists on functional testing, acceptance, and regulatory validation; maintain IT asset inventory and documentation in Service Now.
• Support service transitions such as USLV to USTO server migrations; trigger requisite GMP qualifications and revalidations on impacted documentation and systems.
• Support, maintain, and troubleshoot analytical instrument software platforms (Empower, Chromeleon, Thermal, Nimb Nimbo, Echo) and assist in the transition from Teamo to Omnus (anticipated 2026); utilize specialty applications and enterprise systems including Veeva and CDOCS, ensuring data‑integrity standards.
• Configure data‑management tools to automate data transfers from lab instruments to enterprise file shares; lead data‑integrity assessments using standardized templates.
• Manage incident tickets for lab software and hardware, including user account and licensing management; participate in temperature‑mapping documentation review and PM job walks using Smartsheet or similar systems; partner with instrument vendors for setup, configuration, and upgrades of instrumentation systems.
• Document validation activities, system changes, and issue resolutions in compliance with regulatory standards and corporate policies.

• Bachelor’s degree preferred; 5+ years of experience in lab operations or the biopharmaceutical industry strongly preferred.
• Proven experience with GMP computer system validation and qualification processes, including IQ/OQ.
• Hands‑on experience with laboratory analytical instruments and associated software platforms (Empower, Chromeleon, Nimbus, Echo, Thermal).
• Knowledge of laboratory IT infrastructure and experience with Windows OS upgrade projects.
• Familiarity with compliance and data‑integrity systems such as Veeva and CDOCS.
• Ability to multi‑task on overlapping projects, including server migrations, validations, and software rollouts.
• Strong communication skills to collaborate effectively with scientists, vendors, and IT teams.

Location:

Thousand Oaks, CA (onsite, 5 days a week).

Employment Type:

12‑month W2 contract; non‑exempt.