Work Schedule
Standard (Mon-Fri)Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)The Human Factor Staff Engineer will be a frontline engineer and project manager, driving improvements in Single-Use technologies for biopharmaceutical production. This role focuses on optimizing Single-Use system designs to improve manufacturing performance within the Thermo Fisher BPG team. The Staff Engineer collaborates with our drug substance and drug product partner to refine and advance Single-Use technology offerings. Responsibilities include identifying advancements in biomanufacturing, material sustainability, training, and Single-Use system design. Achieving objectives involves developing innovative engineering solutions and fostering partnerships between internal manufacturers and Single-Use product developers.
Proficiency in single-use technologies for biopharmaceuticals.
Hands-on experience in the clinical and commercial production of monoclonal antibodies or vaccines.
Expertise in contamination and failure investigations for cGMP manufacturing, including root cause analysis and remediation.
Skilled in advanced data collection, measurement, and analysis.
Familiarity with Human Factor Engineering principles.
Over 5 years of experience in continuous improvement methodologies, such as PPI or Lean Manufacturing.
Certification in Six Sigma (Green Belt or Black Belt) and/or Lean methodologies.
Experience in project management and client relations is advantageous.
Outstanding interpersonal and communication skills, including written, oral, and visual presentation abilities.
Proven ability to collaborate and influence across various functional areas, organizational levels, and geographical locations to effectively lead and manage change.
Extensive knowledge of root cause analysis and countermeasure methodologies.
Proficient in leading cross-functional teams through the project and change lifecycle, demonstrating strong project management skills.
Demonstrated dedication to continuous improvement.
Strong problem-solving capabilities.
Proven track record of providing innovative solutions to manufacturing challenges.
Highly organized with meticulous attention to detail, capable of working both independently and as part of a team.
Occasional travel to visit manufacturing sites (5-15%)
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