Computerised System Validation Specialist, prov. Ravenna. Italy

Computerised System Validation Specialist, prov. Ravenna. Italy

We are seeking a Computer System Validation Specialist with operational experience in the Life Sciences sector for our internationally renowned client.

Responsibilities include:

1. Managing test ideation and execution independently.
2. Assisting in software system validation.
3. Drafting validation plans, conducting tests, analyzing results, and preparing validation reports.

Ideal candidates for mid and senior roles should have proven consultancy experience in the pharmaceutical and/or biotech industry.

Job details:

• Employment type: Permanent Contract
• Hours: Monday to Friday, 9 am to 6 pm
• Reporting to: Project leader
• Salary: Dependent on skills and experience

Main Responsibilities:

1. Drafting Validation Plans, Validation Reports, Test Plans, Acceptance Criteria, User Requirements, etc.
2. Writing and reviewing SOPs and work instructions.
3. Preparing Technical Specification documents in collaboration with engineers and managing revisions.
4. Executing IQ/OQ/PQ protocols for computerised systems, processes, and utilities.
5. Conducting technical Impact Assessments.
6. Drafting calibration and maintenance Plans.
7. Reviewing plans, tests, and procedures for IT/OT infrastructure qualification.
8. Knowledge of pharmaceutical industry standards and regulations (ISPE GAMP, GxP, EUDRALEX, FDA CFR 21, etc.).
9. Excellent communication skills in Italian and English at CEFR C1 or higher.
10. Professionalism, formal approach, technical proficiency, and motivation.

What We Offer:

• Training programs
• Performance bonuses
• Overtime pay
• Team building activities

MAASI Enterprises values diversity and is committed to equal opportunities, fair working conditions, and competitive salaries based on responsibilities, skills, and merit.

We offer a competitive salary package, growth opportunities, attractive bonuses, tailored training, and comprehensive benefits.

Join a human-centered company where you are more than just a number.