The Principal Investigator is responsible for the initiation, investigation of process deviations aimed at identification of root cause, and implementation of correct actions to prevent recurrence. The investigator is seen as an investigatory technical expert. Investigator / Initiators are expected to work in a Good Manufacturing Practices (cGMP) environment, have an expert level working knowledge of mammalian manufacturing processes, the ability to manage multiple ongoing projects concurrently as well as mentor and train others within the group, have excellent meeting facilitation and conflict resolution skills, a professional and expert technical writing capability, be action oriented, and be compliant minded while performing investigations.
- Technical writing for the educated but uninformed reader, translating very complex and challenging scientific events into a brief and cohesive report as a finished product.
- Gathering Data from various sources across the site, lead and perform Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, Assessment of event for impact to Safety, Identity, Strength, Quality & Purity (SISQP), Identification of Corrective and Preventative Actions(CAPA’s) to reduce deviation recurrence, performance and leading of Risk Assessments, Causing Mapping, Interviewing.
- Management of multiple projects and timelines concurrently; ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
- Participation in the Daily Management meetings to update leadership on current deviation statuses
- Bachelor of Arts/Science or equivalent combination of education minimum
- Preferred area of study: Biochemistry, Chemical Engineering, Biology or other relevant science discipline
- Advanced years’ experience with investigations / equivalent; advanced experience in the pharma / biotech industry.
- Prior experience working in a manufacturing environment, or troubleshooting manufacturing related issues and technical writing experience required