CSV Engineer - Life Sciences (Hybrid Europe)

Cai; Milano; Ibrido; EUR 34.000 - 46.000; Tempo pieno

Descrizione del lavoro

CAI Milano is seeking a CSV Engineer to develop and execute computer systems validation protocols for life sciences projects in a hybrid role. You will write GxP validation documentation and ensure compliance with 21 CFR Part 11 while collaborating with a global client base.

Ideal candidates have 2–7 years in CSV, GMP exposure, and familiarity with MES and automation platforms such as Rockwell, Siemens, and PAS-X. Travel is required as projects demand.

Competenze

• BS in Computer Science or Engineering or equivalent experience.
• 2-7 years of experience with computer systems validation.
• Experience in GMP environment and aseptic processes is a plus.
• Knowledge of data integrity concepts (GAMP, 21 CFR Part 11).
• Experience with MES, DeltaV, PI is a plus.

Mansioni

• Develop and execute validation protocols and test scripts.
• Identify gaps and direct plans for resolution in CSV.
• Prepare validation documentation (assessments, plans, URS, FRS, RTM).
• Travel domestically and internationally as required.

Conoscenze

CSV engineering

GxP validation

21 CFR Part 11

Data Integrity

Regulatory compliance

Travel ability

Formazione

BS in Computer Science or Engineering

Strumenti

Rockwell

Siemens

Wonderware

PAS-X

Control Logix

Descrizione del lavoro

CAI Milano is seeking a CSV Engineer to develop and execute computer systems validation protocols for life sciences projects in a hybrid role. You will write GxP validation documentation and ensure compliance with 21 CFR Part 11 while collaborating with a global client base.

Ideal candidates have 2–7 years in CSV, GMP exposure, and familiarity with MES and automation platforms such as Rockwell, Siemens, and PAS-X. Travel is required as projects demand.