CSV/ MES Quality Validation

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:

As a Quality Engineer III, you'll help ensure quality excellence and regulatory compliance across manufacturing operations. You'll help ensure our products meet the highest standards while supporting our mission to enable customers to make the world healthier, cleaner and safer. This role combines technical expertise with quality oversight to maintain robust quality management systems, lead investigations, drive continuous improvement, and ensure GMP/ISO compliance.

You'll work with multiple teams to resolve quality issues, conduct risk assessments, manage CAPAs, support audits, and implement quality initiatives. The role requires strong analytical and communication skills to interface effectively with internal teams and external customers/regulators. You'll help establish and maintain quality standards while supporting a culture of continuous improvement and compliance.

REQUIREMENTS:

• Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in quality assurance in regulated industry (pharmaceutical, medical device, or biotech)
• Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field
• ASQ certifications (CQE, CQA) desired
• Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, EMA, etc.)
• Expertise in quality systems including:
• CAPA and deviation management
• Change control
• Risk management and FMEA
• Document control
• Internal/external auditing
• Advanced problem-solving and root cause analysis skills
• Excellent project management abilities
• Strong verbal and written communication skills
• Proficiency with quality management software and MS Office
• Experience with validation and qualification protocols
• Knowledge of statistical analysis and quality tools
• Ability to work both independently and collaboratively
• Strong attention to detail while maintaining broad perspective
• Excellent interpersonal skills for cross-functional collaboration
• May require up to 25% travel
• Additional language skills may be beneficial

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Other

Relocation assistance is not provided. Must be legally authorized to work in the United States now and in the future, without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.