Equipment Validation Specialist

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

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 industry.
• 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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.