Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
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: enabling 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 take science a step beyond by developing solutions for some of the world’s toughest challenges, including protecting the environment, ensuring food safety, and helping find cures for cancer.
Job Description
Join our Quality Control team at Thermo Fisher Scientific, where you will make meaningful contributions to our mission of enabling customers to make the world healthier, cleaner and safer.
As an Senior Scientist Electronic Laboratory Systems, you will perform technical support activities and validation exercise to ensure product quality in a GMP-regulated environment. You will work with analytical equipment and electronic laboratory systems, supporting the qualification, validation, operation, and lifecycle management of QC systems and applications.
Key Responsibilities
- Operate, maintain, and troubleshoot analytical laboratory equipment and electronic laboratory systems.
- Support qualification of analytical equipment and computerized system validation activities for QC laboratory systems.
- Generate, review, and maintain GxP documentation throughout the lifecycle of QC systems, equipment, and applications.
- Evaluate analytical data, document results accurately, and ensure compliance with applicable quality standards.
- Support investigations related to out-of-specification, out-of-expectation, deviations, change controls, and corrective and preventive actions.
- Provide timely technical support to QC laboratory units to ensure reliable laboratory operations.
- Support inspection and audit readiness activities, including gap assessments, remediation actions, and participation in customer or health authority inspections as needed.
- Contribute to the implementation of automated data flows, laboratory process improvements, and Practical Process Improvement initiatives.
- Support data integrity expectations by ensuring reliable, complete, accurate, and compliant laboratory records.
- Collaborate with Quality, Manufacturing, Manufacturing Science and Technology, Supply Chain, Maintenance and Facilities, Procurement, IT, and global laboratory systems teams.
- Adhere to cGMP, quality, EHSS, and site procedures.
- Actively contribute to continuous quality improvement, safety initiatives, deviation reporting, and near-miss follow-up.
- Demonstrate Thermo Fisher Scientific values through accountability, ethical behavior, customer focus, intellectual curiosity, and collaboration.
Required Qualifications
- BSc or MSc in Lifes Sciences (Chemistry, Biochemistry, Physics, Microbiology or equivalent)
- Or IT/Automation background with strong knowledge and experience in the pharma industry
- Strong knowledge of GMP regulations, quality systems, and laboratory compliance requirements.
- Significant experience in a laboratory environment, experience in IT (Programming or Database)
- Computerized System Validation (CSV) and pharma industry Experience in Lab execution Systems as SM LIMS, Chromeleon, Lab X, Empower, etc. is a benefit
- Demonstrated ability to analyze data and support investigations of out-of-specification or atypical results.
- Strong documentation skills and ability to follow written and verbal procedures accurately.
- Familiarity with laboratory information management systems and electronic laboratory systems.
- Knowledge of relevant regulatory standards, including ISO, FDA, USP, and EP expectations.
- Excellent attention to detail, organizational skills, and time management.
- Ability to work independently and collaboratively in a team environment.
