Computer Systems Validation Engineer II

Engineer II - CSV

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:
Join our collaborative team as a Validation Engineer II at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. A Computer Systems Validation (CSV) Engineer is expected to lead and orchestrate the key quality processes pertaining to Projects delivery and operations on GxP regulated systems, governed through various Thermo Fisher Scientific’s Corporate Quality Policies, procedures, work instructions, forms and templates in line with GAMP5 guidelines and Government Regulations (like 21 CFR part 11 and EU Annex 11 etc.). CSV responsibilities start from the concept phase of a system (Risk assessments, planning) through project phase (executions, reporting, checklists, SOPs) and operational maintenance of a computerized system in a validated state till retirement. CSV engineer position offers a challenging opportunity to implement new technologies and develop best Validation practices in a growing organization. This position requires effective collaboration with the contract staff (consultants) guiding the team, overseeing the deliverables, planning, tracking, reporting and coordination with various integrated functions.

REQUIREMENTS:
• Bachelor's degree plus 2 years of validation experience in GMP/regulated environment
• Preferred Fields of Study: Engineering, Life Sciences, Chemistry, or related technical field
• Comprehensive knowledge of cGMP, FDA regulations, and industry standards (ISO, GAMP5)
• Strong technical writing skills for validation documentation
• Experience with IQ/OQ/PQ protocols and execution
• Proficiency in risk assessment and gap analysis
• Experience managing validation projects independently
• Strong data analysis and problem-solving capabilities
• Clear verbal and written communication skills
• Experience with automation systems and computer system validation
• Effective interpersonal skills for team collaboration
• Ability to manage multiple projects
• Experience with quality management systems and documentation

Experience Level

Mid Level