CSV specialist MID/Senior

MAASI Enterprises Ltd; Imola; Hybrid; EUR 32,000 - 54,000; Full time

Benefits offered by this job

Flexible working hours

Remote working

Training programs

Performance bonuses

Team building activities

Health insurance

Job summary

MAASI Enterprises seeks a Mid- to Senior CSV Specialist (Computerised System Validation) to provide consulting in Life Sciences. You will define validation strategies for complex computerised systems, ensuring regulatory compliance and Data Integrity throughout the lifecycle, and act as a reference for stakeholders.

You’ll coordinate project activities, oversee Change Control and Periodic Reviews, and collaborate with cross-functional teams.

Qualifications

• Proven consultancy experience in the Life Sciences sector.
• Strong knowledge of GxP, GAMP 5, FDA 21 CFR Part 11 and EudraLex Annex 11.
• Experience in preparing and reviewing regulated documentation.
• Excellent organization and prioritization across complex projects.
• Excellent interpersonal and communication skills; liaising with cross-functional teams.
• Fluency in English and Italian (C1+).

Responsibilities

• Define validation strategies and manage Change Control and Periodic Reviews for computerised systems.
• Conduct Impact and Risk Assessments (GAMP / Data Integrity) and develop IT/OT qualification plans.
• Prepare and approve validation documentation, including Validation Plans, Validation Reports, URS, FS and DS.
• Develop and support the execution of tests for Commissioning, FAT/SAT and IQ/OQ/PQ protocols.
• Prepare and maintain SOPs, Work Instructions and related training plans.

Skills

Life Sciences consultancy

Excellent communication

Multidisciplinary collaboration

Fluent English and Italian

Strong organizational skills

Tools

GAMP 5

FDA 21 CFR Part 11

EudraLex Annex 11

Job description

We are looking for a Mid – to Senior CSV Specialist (Computerised System Validation) to join our team and provide consulting services to clients operating in the Life Sciences sector.

The successful candidate will be responsible for:

• Defining and leading validation strategies for complex computerised systems supporting regulated facilities and processes, ensuring regulatory compliance and Data Integrity throughout the entire system lifecycle.
• Acting as a technical and strategic point of reference for stakeholders and senior management, while overseeing and coordinating project activities.

MINIMUM SENIORITY

TECHNICAL

COMMERCIAL

QUALITY ASSURANCE

ADMINISTRATION

• Location:
• Travel:
• YES, at least 30%
• Contract Type:
• Permanent
• Working Hours:
• Mon-Fri 9-18 Flexible hours
• Salary range:
• Gross annual salary from €32,000 to €54,000, plus company welfare benefits and performance bonuses in accordance with company policy.
• Department:
• Quality Assurance - Life Science
• Reporting to:
• We offer an excellent growth opportunity

Main responsibilities

Define validation strategies and manage Change Control and Periodic Reviews for computerised systems.
Conduct Impact and Risk Assessments (GAMP / Data Integrity) and develop IT/OT qualification plans.
Prepare and approve validation documentation, including Validation Plans, Validation Reports, User Requirements Specifications (URS), Functional Specifications (FS) and Design Specifications (DS).
Develop and support the execution of tests for Commissioning, FAT/SAT and IQ/OQ/PQ protocols.
Prepare and maintain Standard Operating Procedures (SOPs), Work Instructions (WIs) and related training plans.

Requirements

Proven experience in consultancy within the Life Sciences sector.
Excellent knowledge of GxP standards, GAMP 5, FDA 21 CFR Part 11 and EudraLex Volume 4, Annex 11.
Extensive experience in preparing and reviewing regulated technical documentation.
Strong organisational skills and the ability to manage priorities across complex projects.
Excellent interpersonal and communication skills, with the ability to liaise effectively with multidisciplinary teams and senior management.
Fluency in both English and Italian (C1 level or above), written and spoken.

Nice to have

Experience in the validation of specific application systems such as MES, LIMS, ERP, DCS and SCADA.
Understanding of the relationship between IT/OT architectures and computerised systems.
Familiarity with Cloud environments and SaaS solutions in regulated environments.
Knowledge of cybersecurity principles applied to computerised systems in GxP environments.
Experience with Electronic Document Management Systems (EDMS) and computerised system lifecycle management tools.
Knowledge of Computer Software Assurance (CSA) methodologies.
Experience in managing regulatory audits and inspections.

What We Offer

A comprehensive training program that includes:

• Flexible working hours and remote working.
• Internal and external training programs.
• Performance bonuses.
• Team building activities.

MAASI Enterprises want to be an inclusive and equitable company, we value differences, and welcome people from all walks of life.

We believe in equal opportunities for everyone and we apply fair working conditions and salaries related to assigned responsibilities, skills and personal merit.

Rewarding

A salary pack that matches your responsibilities, a growth plan and attractive bonuses on results base.

Trainings

Internal and external trainings specifically selected on your aptitudes and talent.

A set of benefits, services and affiliations on top to the profession's health insurance.

we're Humans

We're a Company of human beings, before anything else. You'll never be "just a number" here.