CSV Engineer

Katalyst Healthcares & Life Sciences

Hillsboro, OR

Apply

JOB DETAILS

SKILLS

Automation Systems, Biology, Biotech and Pharmaceutical, Code of Federal Regulations, Communication Skills, Computer Science, Computer Systems, Consulting, Data Quality, DeltaV, FDA Requirements, GMP (Good Manufacturing Practices), GxP, ISA Standards, Manufacturing Automation, Manufacturing Systems, Open Systems Interconnection (OSI), Recipe Development, Risk Analysis, Supervisory Control and Data Acquisition (SCADA), System Validation, Systems Administration/Management

LOCATION

Hillsboro, OR

POSTED

30+ days ago

Job Description:
We are seeking an experienced Computer Systems Validation (CSV) Engineer with strong communication skills and a true consultant mindset. The ideal candidate will have solid experience in pharma validation environments and hands-on exposure to manufacturing and automation systems.
Requirements:

Bachelor's degree in computer science, Engineering, Life Sciences, or related field.
5+ years of experience in CSV/CSA frameworks (GAMP) within the Pharma industry.
Hands-on experience with SCADA, OSI-PI, Siemens_desigo, Rockwell FactoryTalk Pharma Suite, DeltaV, and MES.
Experience with system administration and EBR recipe authoring preferred.
Strong understanding of ISA-95 model (Level 2 & Level 3 required; Level 1 is a plus).
Knowledge of FDA regulations (21 CFR Part 11), Annex 11, EU GMP Annex 1, GxP practices, and Data Integrity principles.
Experience performing system and data integrity risk assessments.

About the Company

Katalyst Healthcares & Life Sciences

Resume Resources

Free Resume Templates Free Resume Builder