Equipment Validation Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 re-qualification activities of the Site Equipment reported in the written dedicated protocols and procedures. 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 the systems to be requalified in order to acquire information necessary for the issue of protocols and the execution of activities.
• Issue of re-qualification protocols and dedicated SOPs, through research and acquisition of data and information necessary to define their contents.
• Lead the external consultants in order to assure the correct re-qualification of the system/equipment (requalification Protocols and dedicated SOPs)
• Carry out the analysis of the re-qualification activities and issue the re-qualification reports, in compliance with the 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 the other Site Departments to perform the re-qualification activities.
• Collaborate with the Supervisor to close all the requalification activities on time.

Keys to Success:

Education

• Technical / Scientific Degree (Mechanical Engineering, Chemical Engineering, CTF, Biomedical Engineering, Pharmacy, Industrial Chemistry) or proven experience in qualification/requalification activities.

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!

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.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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