Milestone Technologies, Inc.
Computer Systems Validation Analyst
Milestone Technologies, Inc., Thousand Oaks, California, United States, 91362
Computer Systems Validation Analyst
This is an onsite contract for a Computer Systems Validation analyst.
Must go onsite in Thousand Oaks, CA 5 days a week.
Location:
Thousand Oaks, CA (Onsite 5 days per week)
Schedule:
Monday to Friday, 8:00 AM – 5:00 PM (some flexibility for off-hours may be required)
Summary
Candidates MUST BE LOCAL to be considered.
Milestone is seeking an experienced Computer Systems Validations Analyst with strong GMP computerized validation expertise, particularly in laboratory-based computer systems controlling analytical instruments. The role focuses on supporting compliance, data integrity, and validation activities related to laboratory IT systems and software environments in a pharmaceutical or biotechnology setting.
Key Responsibilities
Computerized System Validations & GMP Compliance:
Lead and support GMP validations including IQ/OQ for laboratory instrument control systems and related software. Manage multiple simultaneous validations (~5 projects) including 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; work closely with scientists for functional testing, acceptance, and regulatory validation steps. Maintain IT asset inventory and documentation through ServiceNow.
Service & Server Transitions:
Support service transitions such as USLV to USTO server migrations, triggering requisite GMP qualifications and revalidations on impacted documentation and systems.
Laboratory Software Expertise:
Support, maintain, and troubleshoot analytical instrument software platforms such as Empower, Chromeleon, Thermal, Nimbus/Nimbo, Echo, and assist in the transition from Teamo to Omnus anticipated in 2026. Utilize specialty applications and enterprise systems including Veeva and CDOCS, ensuring adherence to data integrity standards.
Data Management & Integrity:
Configure data management tools to automate data transfers from lab instruments to enterprise file shares. Lead data integrity assessments using standardized templates to ensure compliance and flexibility for early‑stage evaluations.
Incident Ticket Management:
Manage incident tickets related to lab software and hardware, including user account and licensing management. Participate in activities such as review of temperature mapping documentation and PM job walks using Smartsheet or similar systems. Partner with instrument vendors for setup, configuration, and upgrades of lab instrumentation systems.
Documentation & Reporting:
Document validation activities, system changes, and issue resolutions in compliance with regulatory standards and corporate policies.
Required Skills and Experience
Bachelor’s degree preferred; 5+ years of experience in lab operations or bio/pharmaceutical 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.
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Information Technology
Industries IT Services and IT Consulting, Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
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Must go onsite in Thousand Oaks, CA 5 days a week.
Location:
Thousand Oaks, CA (Onsite 5 days per week)
Schedule:
Monday to Friday, 8:00 AM – 5:00 PM (some flexibility for off-hours may be required)
Summary
Candidates MUST BE LOCAL to be considered.
Milestone is seeking an experienced Computer Systems Validations Analyst with strong GMP computerized validation expertise, particularly in laboratory-based computer systems controlling analytical instruments. The role focuses on supporting compliance, data integrity, and validation activities related to laboratory IT systems and software environments in a pharmaceutical or biotechnology setting.
Key Responsibilities
Computerized System Validations & GMP Compliance:
Lead and support GMP validations including IQ/OQ for laboratory instrument control systems and related software. Manage multiple simultaneous validations (~5 projects) including 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; work closely with scientists for functional testing, acceptance, and regulatory validation steps. Maintain IT asset inventory and documentation through ServiceNow.
Service & Server Transitions:
Support service transitions such as USLV to USTO server migrations, triggering requisite GMP qualifications and revalidations on impacted documentation and systems.
Laboratory Software Expertise:
Support, maintain, and troubleshoot analytical instrument software platforms such as Empower, Chromeleon, Thermal, Nimbus/Nimbo, Echo, and assist in the transition from Teamo to Omnus anticipated in 2026. Utilize specialty applications and enterprise systems including Veeva and CDOCS, ensuring adherence to data integrity standards.
Data Management & Integrity:
Configure data management tools to automate data transfers from lab instruments to enterprise file shares. Lead data integrity assessments using standardized templates to ensure compliance and flexibility for early‑stage evaluations.
Incident Ticket Management:
Manage incident tickets related to lab software and hardware, including user account and licensing management. Participate in activities such as review of temperature mapping documentation and PM job walks using Smartsheet or similar systems. Partner with instrument vendors for setup, configuration, and upgrades of lab instrumentation systems.
Documentation & Reporting:
Document validation activities, system changes, and issue resolutions in compliance with regulatory standards and corporate policies.
Required Skills and Experience
Bachelor’s degree preferred; 5+ years of experience in lab operations or bio/pharmaceutical 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.
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Information Technology
Industries IT Services and IT Consulting, Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr