Overview
On Site
Full Time
Skills
Computer Science
Pharmaceutics
Biotechnology
Life Sciences
GxP
Good Manufacturing Practice
Documentation
GAMP
Computerized System Validation
Technical Writing
Attention To Detail
Manufacturing
LIMS
MES
SCADA
Instrumentation
Auditing
Management
Job Details
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.
- Experience authoring SOPs for laboratory or manufacturing equipment.
- Familiarity with LIMS, MES, SCADA, or laboratory instrumentation.
- Prior exposure to audits or regulatory inspections.
- bility to manage multiple projects under tight deadlines.
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