Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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:

At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations that make the world healthier, cleaner and safer. You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment.

REQUIREMENTS:

• Bachelor's Degree required, no prior experience required. Experience in pharmaceutical, medical device or regulated industry preferred

• Preferred Fields of Study: Chemistry, Biology, Biotechnology, Engineering, or related scientific/technical field

• Knowledge in computerized systems installed in the Manufacturing and QC Department

• CSV

• Knowledge of Empower (preferred)

• Ability to work independently and collaborate effectively with cross-functional teams

JOB DESCRIPTION:

• Manage user permission/profile not managed by IT for CFR 21 part 11 systems and password, recipes and other parameters for not CFR 21 part 11 instrument like balances, pH-meters;

• User Management

• Execute back up of relevant data in case of manual processes;

• Support Automation and Maintenance Team for troubleshooting

• Support departments during system SOP drafting; follow the equipment/computer system validation activities;

• Support the Team Write specific procedures an maintain their own managed computer system list according to SOP for SOD;

• Complete the DI risk assessment for new systems

• If needed, meet with vendors to discuss software capabilities in regards to 21CFR Part 11 compliance;

• Collaborate on projects to meet vendor, business, and regulatory requirements.