Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
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.
Description:
Lead team responsible for monitoring and trending single-use manufacturing failure rates by engineering technology and unit operation
Act as a mentor for investigation of single-use failures in collaboration with Operations and Quality
Support QA efforts to increase single-use manufacturing success rates across manufacturing sites
Coordinate and lead lessons learned activities with Bioproduction Engineering to improve single-use products
Identify, prioritize, and lead practical process improvement initiatives that are aligned with business objectives
Act as expert to site resources in the areas of practical process improvement and lean principles implementation
Support improvements in metric planning reviews to support industry publications, case studies, and presentations.
Deliver clear and concise verbal and written presentations to collaborators
Communicate recommendations and solutions to operations and leadership team members to effectively establish support for implementation of corrective and preventative actions related to single use materials.
Apply the manufacturing network to gain insight into daily operations and collect feedback from employees and leaders. This will help identify areas for continuous improvement in Single Use Technologies.
Support the optimization of the production process, continuously working to increase project savings on the technical side, while adhering to cGMP and company procedures.
Education
Bachelor's degree or equivalent experience in biochemical engineering, biopharmaceutical engineering, chemical engineering, biochemistry, biology or a related field.
Experience
8+ years of relevant industry experience in biopharmaceutical cGMP production, process engineering, or process development preferred
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.
Knowledge, Skills, Abilities
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%)
