Job Description
Roles & Responsibilities:
Bachelor's degree in engineering, Computer Science, Life Sciences, or related field. -+ 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 guidance. CFR Part and Annex . 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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