Quality Engineer II in Facilities & Metrology

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

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 Facilities & Metrology team and make a meaningful impact on quality systems and regulatory excellence. As a Quality Engineer II in Facilities & Metrology with a focus on compliance, you'll work directly with quality systems to ensure manufacturing operations meet the highest standards while collaborating with cross-functional teams to drive continuous improvement and regulatory compliance.

Quality & Deviations Management:

Lead investigations for equipment breakdowns or process failures. Identify root causes and implement Corrective and Preventive Actions (CAPAs) to address quality issues and prevent recurrence.

Commissioning & Qualification:

Oversee the development and execution of User Requirement Specifications (URS), Factory/Site Acceptance Testing (FAT/SAT), and facility commissioning.

Documentation & Compliance Metrics:

Manage regulated documentation including Standard Operating Procedures (SOPs), change controls, deviations, and periodic reviews. Track quality metrics and maintain compliance reporting to demonstrate adherence to quality systems.

Audit Support:

Provide technical expertise and documentation to support successful audit outcomes. Support departmental efforts tied to audit observations

Work closely with quality assurance, operations, validation, and regulatory teams to maintain robust quality systems that support manufacturing excellence and enable our customers to make the world healthier, cleaner, and safer.

REQUIREMENTS

• Advanced Degree with no prior experience, or Bachelor's degree in Chemical, Mechanical, Electrical, Pharmaceutical Engineering, or equivalent relevant experience. 2+ years of experience supporting quality systems, validation, or GMP documentation in an FDA-regulated or biotech environment

• 2+ years of experience supporting quality systems, validation, or GMP documentation in an FDA-regulated or biotech environment

• 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

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.