Quality Engineer II — Compliance & CAPA Specialist

ThermoFisher Scientific; St. Louis (MO); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Healthcare

Annual bonus

Employee benefits

Job summary

Thermo Fisher Scientific in the United States is seeking a Quality Engineer II within Facilities & Metrology focused on compliance. You’ll work with quality systems to ensure manufacturing operations meet cgmp standards and support continuous improvement across cross‑functional teams.

You will lead deviation investigations, CAPA, and the documentation program, oversee URS, FAT/SAT, and commissioning, and provide audit support to ensure inspection readiness and robust quality systems.

Qualifications

• 2+ years of experience supporting quality systems, validation, or GMP documentation.
• Exceptional written and verbal communication skills with the ability to effectively present complex technical information to diverse audiences
• Proven ability to collaborate and build strong partnerships across multiple departments including Quality, Operations, Regulatory, Validation, Facilities, and Manufacturing
• Demonstrated success working in cross-functional team environments and influencing stakeholders at all levels
• Strong interpersonal skills with the ability to facilitate meetings, lead discussions, and drive consensus among multiple teams
• Deep understanding of current Good Manufacturing Practices (cGMP), process safety management, and cleanroom design standards
• Strong knowledge of GMP, ISO standards, and regulatory requirements
• Proficiency with document and quality management systems like TrackWise, Veeva, or Kneat
• Experience with deviation investigations, root cause analysis, and CAPA management
• Knowledge of commissioning, qualification, and validation processes (C&Q)
• Experience with User Requirement Specifications (URS) and Factory/Site Acceptance Testing (FAT/SAT)
• Proficient in managing SOPs, change controls, and regulated documentation
• Experience supporting FDA, EMA, or other regulatory inspections and audits
• Strong analytical and problem-solving capabilities
• Proficiency with Microsoft Office suite and manufacturing software systems
• Ability to work in cleanroom environments and comply with required PPE/gowning procedures
• Available to work flexible hours and provide on-call support as needed

Responsibilities

• Lead investigations for equipment breakdowns or process failures and implement CAPAs.
• Oversee URS, FAT/SAT, and facility commissioning.
• Manage SOPs, change controls, deviations, and periodic reviews.
• Provide documentation support for audits and regulatory submissions

Skills

GMP knowledge

Regulatory compliance

CAPA management

Cross-functional collaboration

Root cause analysis

Documentation management

Audit support

Problem solving

Communication skills

Analytical thinking

Education

Bachelor's degree in Chemical/Mechanical/Electrical/Pharmaceutical Eng or equivalent

Advanced degree in relevant field

Tools

TrackWise

Veeva

Kneat

Regulatory software

Job description

Thermo Fisher Scientific in the United States is seeking a Quality Engineer II within Facilities & Metrology focused on compliance. You’ll work with quality systems to ensure manufacturing operations meet cgmp standards and support continuous improvement across cross‑functional teams.

You will lead deviation investigations, CAPA, and the documentation program, oversee URS, FAT/SAT, and commissioning, and provide audit support to ensure inspection readiness and robust quality systems.