Senior CSV Consultant

Confidential; Italia; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A Milan-based engineering firm is seeking a hands-on Senior CSV Consultant with over 5 years of experience in Computer System Validation. The role involves ensuring compliance with GMP standards and contributing to system validations and oversight. Ideal candidates should have knowledge of manufacturing SCADA and ERP systems, along with cybersecurity principles. This position offers opportunities for growth into leadership roles.

Competenze

• 5+ years of experience in Computer System Validation, preferably in pharmaceuticals.
• Direct knowledge of manufacturing SCADA and ERP systems.
• Knowledge of cyber security principles applicable in industrial settings.
• Ability to manage compliance submissions and oversee validated systems.

Mansioni

• Perform hands-on CSV activities and compliance checks.
• Ensure data integrity and compliance with GMP standards.
• Support submission and maintenance of compliant systems.
• Collaborate with stakeholders to expand the commercial area.

Conoscenze

Computer System Validation (CSV)

Manufacturing SCADA systems

ERP systems

GMP standards

Cybersecurity principles

Descrizione del lavoro

COMPANY

They are a Milan-based company that provides engineering, validation, and quality assurance services for new and existing systems, equipment, and facilities. They also offer auditing, testing, commissioning, and automated system validation in compliance with international standards.

CANDIDATE PROFILE

We are seeking a hands-on Senior CSV Consultant with 5+ years of experience in Computer System Validation, ideally in pharmaceutical and with cybersecurity exp. The candidate should have direct knowledge and experience with systems such as manufacturing SCADA and ERP. This role is pivotal to ensuring compliance with data integrity standards and requires a proactive individual who can manage system compliance submissions and oversee systems they have directly validated. This is a mid- to long-term project with the potential to grow into a leadership position around which a dedicated business unit could be developed. The ideal candidate should be adaptable, multifaceted, and capable of contributing to both technical and commercial growth. 7

RESPONSIBILITIES

Hands-on CSV activities, including system validation and compliance checks. Ensure data integrity and compliance with GMP and other relevant standards. Support the submission and maintenance of compliant systems. Involvement in C&Q and shakedown activities. Collaborate with internal and external stakeholders to expand the commercial area.

JOB REQUIREMENTS

Minimum of 5+ years of experience in CSV, particularly with manufacturing systems (SCADA (e.g. DeltaV) , ERP). Strong understanding of GMP standards and compliance requirements. Ability to adapt to different environments and manage shifting priorities. Knowledge of cybersecurity principles and their application in industrial settings. Degree is not mandatory but considered an advantage Italian level native or advanced

LOCATION

Milan, Italy Work travel according to need