Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAs 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 observationsWork 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.REQUIREMENTSAdvanced 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 environment2+ years of experience supporting quality systems, validation, or GMP documentation in an FDA-regulated or biotech environmentExceptional written and verbal communication skills with the ability to effectively present complex technical information to diverse audiencesProven ability to collaborate and build strong partnerships across multiple departments including Quality, Operations, Regulatory, Validation, Facilities, and ManufacturingDemonstrated success working in cross-functional team environments and influencing stakeholders at all levelsStrong interpersonal skills with the ability to facilitate meetings, lead discussions, and drive consensus among multiple teamsDeep understanding of current Good Manufacturing Practices (cGMP), process safety management, and cleanroom design standardsStrong knowledge of GMP, ISO standards, and regulatory requirementsProficiency with document and quality management systems like TrackWise, Veeva, or KneatExperience with deviation investigations, root cause analysis, and CAPA managementKnowledge 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 documentationExperience supporting FDA, EMA, or other regulatory inspections and auditsStrong analytical and problem-solving capabilitiesProficiency with Microsoft Office suite and manufacturing software systemsAbility to work in cleanroom environments and comply with required PPE/gowning proceduresAvailable to work flexible hours and provide on-call support as neededBenefitsWe 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!OtherRelocation 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.