Job Details

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Roles & Responsibilities

• Bachelor's degree in engineering, Computer Science, Life Sciences, or related field.
• 2-10+ years of experience in computerized systems validation within pharmaceutical, biotechnology, or life sciences industries.
• Direct experience with GxP equipment, IT systems, or manufacturing automation systems.
• FDA and cGMP regulations and documentation practices.
• GAMP 5 guidance.
• 21 CFR Part 11 and Annex 11.
• Computer system validation methodologies.
• Familiarity with risk-based validation execution strategies.
• Strong technical writing skills with attention to detail.

Preferred Skills

• Experience authoring SOPs for laboratory or manufacturing equipment.
• Familiarity with LIMS, MES, SCADA, or laboratory instrumentation.
• Prior exposure to audits or regulatory inspections.
• Ability to manage multiple projects under tight deadlines.

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Irvine, CA $141,000.00-$202,000.00

Seniority level

Mid-Senior level

Employment type

Contract

Industries

Pharmaceutical Manufacturing