Manufacturing Lead Investigator
Takeda
- Cambridge, MA
- $67,900-106,700 per year
- Permanent
- Full-time
- Investigate and document findings and influence assessment for deviations mostly minor, some major
- Provide subject matter expertise on manufacturing process to support deviations owned by other departments
- Author calibration Out of Tolerance (OOT) impact assessments
- Author Environmental Monitoring (EM) excursions impact assessments
- Participate in continuous improvement initiatives
- Demonstrate capability to resolve process related issues of low to mid- level complexity.
- Can occasionally lead/resolve complex problems if according to experience and skills.
- Strives to create fresh solutions to issues.
- Actively participate on teams with internal/external SMEs.
- Assist assigned functional area leads in driving problems to resolution.
- Manufacturing
- QC / QA
- Support functions (Engineering, Facilities, Validation, Process Development, etc.)
- Bachelor's in Science, Engineering or a related discipline
- 2-5 years related experience in the manufacturing and development of biologics or pharmaceuticals
- Previous technical writing experience
- Provides clear, concise and technically sound written & verbal communications in a timely manner with limited input from manager or senior team members
- Proactively contributes to a discussion in a constructive and positive manner in group settings.
- Demonstrate high-level of professional and when communicating with cross-functional teams and others at all levels of the organization
- Seeks to identify sources of conflict and resolve independently or under the guidance of senior team members / managers.
- Proficient with the following software applications
- Microsoft Visio, Project, and SharePoint
- TrackWise, or equivalent system
- LIMS, SAP, OSI/PI applications a plus
- Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.