Overview
On Site
Depends on Experience
Contract - W2
Contract - Independent
Skills
Experience with Chromatography
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 LIMS
MES
SCADA
or laboratory instrumentation.
Prior exposure to audits or regulatory inspections.
Ability to manage multiple projects under tight deadlines.
Job Details
CSV Engineer
JPC - 6850
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 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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