Overview
On Site
$55 - $60
Contract - W2
Contract - Independent
Contract - 6 month(s)
No Travel Required
Skills
Design Specifications (DS
Installation Qualification (IQ
GMP
Job Details
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)
Visa: USC, GC & H4 EAD
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.
- Working knowledge of:
- 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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