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Quality Engineer II
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27-3435995 Patheon Biologics LLC
Berkeley, MO (In Person)
Full-Time
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Job Description
Work Schedule Standard Office Hours (40/wk)
Environmental Conditions Cleanroom:
no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) 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 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.