Job Code : - 6850-2-11 / 21
Hi Team,
Please align the best possible resources ASAP.
CSV Engineer
Costa Mesa, CA or Seattle, WA(On-site)
Key Responsibilities :
- Develop and maintain Design Specifications (DS) for computerized and automated systems.
- Author and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
- Generate and review validation reports and Validation Summary Reports (VSRs).
- Author and maintain Standard Operating Procedures (SOPs) for validated systems and equipment.
- Support implementation of CSV activities for IT and manufacturing automation systems in GMP environments.
- Apply risk-based validation approaches in alignment with industry standards and regulatory guidance.
- Partner with Quality, Engineering, and IT teams to align validation deliverables with compliance and business needs.
- Contribute to inspection readiness by ensuring validation documentation meets regulatory expectations.
Qualifications :
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.Experience with Chromatography
Working knowledge of :FDA and cGMP regulations and documentation practices
GAMP 5 guidance21 CFR Part 11 and Annex 11Computer system validation methodologiesFamiliarity 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.