Equipment Validation Compliance Specialist
On-siteMonza, Lombardy, Italy
Job Summary
Review and approve qualification protocols, reports, and technical documentation for equipment and systems requiring qualification, ensuring compliance with cGMP, FDA regulations, and internal procedures. Support equipment qualification activities by providing quality oversight, evaluating technical issues, and maintaining Standard Operating Procedures through document preparation and periodic review. Prepare required documentation and information for customer and regulatory inspections, participate in audits, and monitor the implementation of quality policies within the area of responsibility. This role contributes to continuous improvement initiatives and product quality at Thermo Fisher Scientific, a global leader in serving science with brands including Thermo Scientific and Invitrogen.
Required Qualifications
- Bachelor's or Master's Degree
- At least 5 years of experience in the pharmaceutical industry
- Experience in sterile pharmaceuticals manufacturing environments
- Knowledge of equipment and system validation principles, including IQ/OQ/PQ
- Knowledge of FDA/EMA validation regulations and industry standards
- Good knowledge of cGMP regulations
- Knowledge of data integrity requirements and 21 CFR Part 11 compliance
- Experience with risk assessment methodologies (FMEA)
- Expertise in Microsoft Office suite
- English: Intermediate (written and spoken)
- Ability to work independently and as part of cross-functional teams
- Quality-oriented mindset
- Critical thinking and analytical skills
- High attention to detail and accuracy
- Ability to manage multiple priorities effectively
- Travel between sites
- Flexible schedule
Desired Qualifications
- Preferred Fields of Study: Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, Biotechnology, Biology, Engineering or related scientific field
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.