Equipment Validation Compliance Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

• DESCRIPTION
• Join us as a Equipment Validation Compliance Specialist at Thermo Fisher Scientific, where you'll contribute to ensuring product quality and regulatory compliance. In this position, you'll be responsible for reviewing and approving qualification protocols, qualification reports and technical documentation related to equipment and systems requiring qualification, ensuring compliance with applicable regulatory requirements and company procedure. Working with cross-functional teams, you'll help maintain our high standards of quality while supporting continuous improvement initiatives. This role offers excellent opportunities for professional growth within an established leader in serving science .

KEY RESPONSIBILITIES

Review technical documentation related to equipment and systems requiring qualification, ensuring compliance with current regulatory requirements (cGMP, FDA, and other applicable regulations) and internal procedures.

Review and approve qualification protocols and reports (IQ/OQ/PQ), ensuring their accuracy, completeness, and compliance with applicable GMP regulations and company standards.

Support equipment qualification activities by providing quality oversight and evaluating technical issues to ensure proper execution of IQ/OQ/PQ protocols in accordance with approved procedures.

Support the Team Leader during customer and regulatory inspections by preparing and providing the required documentation and information, and participating in audits when needed, ensuring compliance with current GMP requirements.

Ensure adherence to company quality standards by monitoring the implementation of procedures within the area of responsibility, in line with corporate quality policies and procedures.

Maintain and continuously update Standard Operating Procedures (SOPs), operating procedures, methods, and validation documentation related to the area of responsibility through document preparation and periodic review, ensuring ongoing compliance with current GMP requirements.

• REQUIREMENTS
• •Education:

Bachelor's or Master's Degree required.

Preferred Fields of Study: Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, Biotechnology, Biology, Engineering or related scientific field.

Professional experience

At least 5 years of experience in the pharmaceutical industry, preferably within Quality Assurance and Equipment Validation.

Technical knowledge

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.

Language

English: Intermediate (written and spoken).

Personal skills

• 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.

Additional information

• Travel between sites may be required.
• Flexible schedule may be necessary for time-sensitive validation activities.