Responsibilities:
- Lead and/or support manufacturing investigations, identifying root cause, assessing impact, and recommending corrective actions.
- Evaluate issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to resolve root cause.
- Ensure consistent application of standardized work, engineering, project management, and process tools.
- Provide technical support to the manufacturing shop floor for problems and issues.
- Design and conduct experimental protocols using technical operations lab facilities and/or production equipment at full scale.
- Author and update technical and manufacturing documents for investigations, process design/definition, engineering studies, process demonstrations, change control, and validation.
Qualifications:
- B.S. in Engineering or Sciences.
- Minimum 1 year post-bachelorβs experience in GMP manufacturing and/or technical support of GMP operations (or M.S. with <1 year).
Required skills/experience:
- Ability to drive results.
- Strong communication and collaboration; ability to drive accountability.
- Strong problem-solving.
- Adaptability; Corrective Action Management; Data Analysis; Equipment Troubleshooting; GMP/Good Manufacturing Practices; Lean Manufacturing; Operations/Production Support; Personal Initiative; Process Optimization; Project Management/Planning/Resource Management; Root Cause Analysis (RCA); Technical Writing; Technology Transfer; Vaccine Manufacturing; Writing Technical Documents.