Work Schedule

Environmental Conditions

Job Description

DESCRIPTION:

Join our engineering team and make a meaningful impact on quality systems and regulatory excellence. As a Quality Engineer II in Manufacturing Engineering 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: Act as a Subject Matter Expert (SME) during internal audits and external regulatory inspections (e.g., FDA, EMA). 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
•    Bachelor's degree nad 2 + years experience or HIgh School Diploma or equivalent with 5 + years experience.
•    Experience supporting quality systems, validation, or GMP documentation in an FDA-regulated or biotech environment preferred.
•    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.