CSV Engineer: GMP Validation for Biotech & Pharma

Cagents; Australia; Presencial; AUD 55.000 - 74.000; Jornada completa

Descripción de la vacante

CAI is seeking a CSV Engineer to develop and execute validation protocols for computer systems in life sciences environments. You will write assessments, URS, FRS, RTM, and summary reports, ensuring compliance with GxP and 21 CFR Part 11.

Travel domestically and internationally as required; strong English communication is essential. Experience with MES, DeltaV, PI, and major systems (Rockwell, Siemens, Honeywell, etc.) is a plus.

Formación

• BS in a Computer Science or Engineering field or equivalent experience.
• 2-7 years’ experience with Computer systems validation.
• 2 years’ experience working in a GMP environment.
• Aseptic process knowledge.
• CSV and Automation experience in filling line.
• Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired.
• Experience in biotech and pharma is preferred over medical device.
• Experience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.

Responsabilidades

• Develop and execute validation protocols and test scripts.
• Identify gaps and consult on and direct plans for resolution.
• Write GxP computer validation documentation such as assessments, URS, FRS, RTM, and summary reports.
• Ensure Data Integrity with GAMP and 21CFR Part 11 compliance.
• Review and maintain validation deliverables in GMP environments.

Conocimientos

GxP validation

21 CFR Part 11

Data Integrity

English communication

Educación

BS in CS or Engineering

Herramientas

MES

DeltaV

PI

Rockwell

Siemens

Descripción del empleo

CAI is seeking a CSV Engineer to develop and execute validation protocols for computer systems in life sciences environments. You will write assessments, URS, FRS, RTM, and summary reports, ensuring compliance with GxP and 21 CFR Part 11.

Travel domestically and internationally as required; strong English communication is essential. Experience with MES, DeltaV, PI, and major systems (Rockwell, Siemens, Honeywell, etc.) is a plus.