Equipment Validation Specialist Lazio

Equipment Validation Specialist
Roma
Lazio, Lazio

Work Schedule

Standard (Mon-Fri)

**Environmental Conditions

Office

**Location/Division Specific Information

Ferentino, Italy

**Discover Impactful Work**:

Ensure the execution of the qualification activities of the Site Equipment reported in the written protocol.

Assure the tests are in line with the main guidelines and GMP.

**A day in the Life**:

- Perform the analysis and evaluation of technical documentation for system to be qualified in order to acquire information necessary for the issue of protocols and the execution of activities.

- Issue of qualification protocols (IQ-OQ-PQ Protocols), through research and acquisition of data and information necessary to define their contents.

- Lead the external consultants in order to assure the correct qualification of the system/equipment (IQ-OQ-PQ Protocols)

- Carry out the analysis of the qualification activities and issue the qualification reports (IQ-OQ-PQ report), in compliance with current regulations (current EU GMP, US GMP) and company quality standards.

- Support the Quality Department in preparing Customer Audits and Regulatory Inspections, providing necessary information and documentation.

- Collaborate with other Site Departments in order to achieve the goal of the company's projects.

- Participate in calls/meetings with customers/clients to support the discussion on topics related to equipment qualification.

- Collaborate with the Team Leader to close on time all assigned project.

**Keys to Success**:

**Education**:

- Technical / Scientific Degree (Mechanical Engineering, Chemical Engineering, CTF, Biomedical Engineering, Pharmacy, Industrial Chemistry)

**Experience**:

- Experience in pharmaceutical industries

- At least 2 years' experience in Equipment Qualification Department

**Knowledge, Skills, Abilities**:

- Knowledge of the main pharmaceutical machines/systems

- Fluent in English

- Good Team-worker

- Good problem-solving abilities

- Proficiency in Microsoft Office suite and electronic systems such as Documentum and Trackwise

- Be prepared to work with conflicting priorities, under time constraints and in a dynamic team environment

**Benefits**:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.

Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.

We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!