Title : Sr. Scientist Engineer Investigator
Duration: 12 Months Contract
The Sr. role will be assigned more complex deviation investigations, and often need to create and facilitate teams to execute all elements in a timely matter. Deviation investigation includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems. The successful incumbent must interface closely with different functional organizations and management, including Quality Assurance teams.
Knowledge, Skills, and Abilities:
* Advanced working experience of deviation investigations utilizing root cause analysis tools.
* Working experience in the CAPA process and ability to identify and verify effectiveness.
* Advanced technical writing skills, and capability to review, improve, and approve investigation reports from more junior team members
* Capability to kickoff and lead limited duration investigation teams, to ensure timely completion of more complex investigations requiring scientific work outside of S12 site
* Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
* experience supporting health authority inspections. Sr. scientists/engineers will often defend more complex investigation reports in Regulatory Investigator questioning during Health Authority audits.
* Knowledge of data trending and tracking, including use of statistical analysis software a plus.
* Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.
* Ability to set priorities, manage timelines and effectively react/manage changing priorities.
* Ability to work with management (global and site) and support corporate and departmental goals.
* Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.
* Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).
* Hands on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control. Proven delivery of complex investigation reports is required for the Sr. Level role.
* Ability to train and mentor junior associates to foster and develop their expertise.
Education and Experience: * Requires a Bachelors Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
* Minimum 5 years of relevant work experience, preferably in a health authority regulated environment.
* Sr Level requires demonstrated capability in medium and high-risk deviation reports or equivalent proven experience
* Previous experiences working in a biopharmaceutical manufacturing facility and an aseptic environment is preferred (CAR T a plus).
* An equivalent combination of education and experience may substitute.
DUTIES AND RESPONSIBILITIES:
* Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
* Lead medium and high -risk investigation teams with the ability to summarize progress to Sr. Management, collect information from the triage team, and gather necessary supporting data from technical and quality teams outside of S12
* Perform GEMBA walks with stakeholders to better understand process steps, and evaluate Root Cause analysis.
* Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
* Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
* May Initiate change control documentation
* Identify functional area SMEs to perform impact assessments as part of the change management process.
* Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.
* Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
* Lead deviation investigation defense during audits and site inspections for QC compliance related inquiries.
* Handle complex issues and solve problems with minimal guidance. Manage teams to support more complex investigations
* Provide mentorship, guidance and training to junior members.
* Serve as author or technical reviewer of departmental procedures as appropriate.
* Support manufacturing and Quality Control testing of CAR- T products as needed.
* Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
* Continuously support S12, living the patients first mission and fostering a Right First Time mindset.