Key skills
Quality EngineeringcGMP manufacturingDeviation ManagementInvestigation ManagementRoot Cause AnalysisCorrective and Preventive Action (CAPA)Change ControlQuality Risk Management (QRM)Failure Mode and Effects Analysis (FMEA)Qualification protocols (IQ/OQ/PQ)FDA 21 CFR Parts 11, 210, 211EU GMP guidelinesStatistical analysisProcess control toolsData integrityTrackWiseVeeva Vault5-WhysFishbone (Ishikawa) diagramsFault Tree AnalysisStatistical AnalysisVaultRisk Management
About this role
Intellectt Inc is seeking a highly motivated and technically proficient Quality Engineer to join their Quality Operations and Compliance team. The role involves providing quality engineering oversight for manufacturing processes, equipment qualification, and product life cycle management within a regulated cGMP manufacturing facility.
Responsibilities:
- Lead and support technical deviation investigations, non-conformances (NCs), and out-of-specification (OOS) results
- Conduct rigorous root cause analyses (RCA) and collaborate cross-functionally to develop robust documentation
- Own, design, and manage Corrective and Preventive Action (CAPA) plans
- Ensure effective implementation and perform rigorous effectiveness checks to prevent recurrence
- Review, assess, and approve engineering and process change controls, ensuring that modifications do not impact the validated state of manufacturing equipment, utilities, or systems
- Facilitate and execute Quality Risk Management (QRM) tools, including Failure Mode and Effects Analysis (FMEA), to identify and mitigate risks across manufacturing processes and equipment
- Partner with Validation and Manufacturing teams to review and approve qualification protocols (IQ/OQ/PQ), validation master plans, and technical engineering reports
- Ensure all operations align with FDA 21 CFR Parts 11, 210, and 211, EU GMP guidelines, and current ISPE baseline guides
Requirements:
- Bachelor of Science (BS) degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, or a related scientific/engineering discipline
- 3-10 years of direct Quality Engineering experience in a cGMP commercial pharmaceutical or biotechnology manufacturing environment
- Strong working knowledge of statistical analysis, process control tools, and data integrity principles
- Demonstrated expertise using root cause analysis tools such as 5-Whys, Fishbone (Ishikawa) diagrams, and Fault Tree Analysis
- Exceptional technical writing capabilities, sharp attention to detail, and the ability to articulate complex quality issues clearly to cross-functional teams
- Experience with automated quality management systems (e.g., TrackWise, Veeva Vault) is highly desirable