Scientist/Engineer

Innova Solutions is immediately hiring a Scientist / Engineer

Job Title : Scientist / Engineer

Position type : Full-time Contract

Duration : 12 Months

Location : Summit, NJ (100% onsite)

As a Scientist / Engineer you will :

The Scientist / Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations.

This 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, including Quality Assurance teams.

Required Competencies :

• Working experience of deviation investigations utilizing root cause analysis tools.
• Working experience in the CAPA process and ability to identify and verify effectiveness.
• Technical writing skills and ability to collaborate effectively in cross functional teams.
• Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.
• Ability to support health authority inspections.
• 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.
• Ability to train new team members on the investigation process

Education and Experience :

• Requires a Bachelor’s Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
• Minimum 3 years of relevant work experience, preferably in a health authority regulated environment.
• Previous experience working in a biopharmaceutical manufacturing facility 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 investigations and cross functional investigation teams, and close reports in a timely manner
• 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.
• Support deviation investigation defense during audits and site inspections for QC compliance related inquiries.
• Handle complex issues and solve problems with minimal guidance.
• Provide training to new investigations team 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.

Thank you!

Sara Almas

Team Recruitment

PAY RANGE AND BENEFITS :

Pay range : $ 45.00 -$ 48.94 Per Hour.

Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits : Innova Solutions offers benefits( based on eligibility) that include the following : Medical & pharmacy coverage, Dental / vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).