Senior Computer Systems Validation Engineer (GMP/Biotech)

Cagents; Milano; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

CAI is seeking a Computer Systems Validation (CSV) Engineer to develop and execute validation protocols and scripts, identify gaps, and direct plans for resolution in a GMP environment. You will write GxP validation documentation including URS, FRS, RTM, and reports and ensure data integrity per 21 CFR Part 11 guidelines.

Ideal candidates hold a BS in Computer Science or Engineering with 2-7 years of CSV experience and exposure to GMP, aseptic processes, MES, DeltaV, and PI.

Competenze

• 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
• filling line CSV and Automation experience
• 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.

Mansioni

• The CSV Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution
• This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports
• Lead validation activities to ensure compliance and data integrity in GMP environments

Conoscenze

CSV validation

GxP knowledge

Data integrity

GMP experience

English communication

Travel willingness

Formazione

BS in Computer Science or Engineering

Strumenti

MES

DeltaV

PI

PAS-X

Syncade

FactoryTalk

Descrizione del lavoro

CAI is seeking a Computer Systems Validation (CSV) Engineer to develop and execute validation protocols and scripts, identify gaps, and direct plans for resolution in a GMP environment. You will write GxP validation documentation including URS, FRS, RTM, and reports and ensure data integrity per 21 CFR Part 11 guidelines.

Ideal candidates hold a BS in Computer Science or Engineering with 2-7 years of CSV experience and exposure to GMP, aseptic processes, MES, DeltaV, and PI.