Equipment Validation Specialist

ThermoFisher Scientific; Ferentino; On-site; EUR 42,000 - 65,000; Full time

Benefits offered by this job

Healthcare

Annual bonus

Career development

Job summary

Thermo Fisher Scientific in Ferentino, Italy, seeks a qualified equipment qualification professional to ensure IQ/OQ/PQ execution for site systems. The role involves evaluating technical documentation, leading external consultants, and delivering GMP-compliant qualification reports.

You will support audits, collaborate with multiple site departments, and participate in client discussions on qualification topics. Fluency in English and 2+ years in pharma equipment qualification are required.

Qualifications

• Technical or scientific degree in engineering or related field.
• At least 2 years’ experience in Equipment Qualification in pharmaceutical industry.
• Knowledge of main pharmaceutical machines and systems.
• Fluent in English.
• Ability to work with conflicting priorities and under time constraints.

Responsibilities

• Analyze and evaluate technical documents for systems to be qualified.
• Issue IQ-OQ-PQ Protocols with data collection.
• Lead external consultants to ensure correct qualification of systems/equipment.
• Prepare qualification reports in line with EU/US GMP and company standards.
• Support Quality Department for customer audits and regulatory inspections.
• Collaborate with Site Departments to achieve project goals.
• Participate in calls/meetings with customers on qualification topics.
• Collaborate with Team Leader to close projects on time.

Skills

Fluent English

Team player

Problem solving

Priorities management

Pharma equipment knowledge

Education

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

Tools

Microsoft Office

Documentum

Trackwise

Job description

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 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!

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.

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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.