Specialist, Equipment Validation

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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!