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Engineer

3 months ago

Summit, United States TSR Consulting Full time

79832

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

Our client, a leading pharmaceutical company is hiring an Associate Scientist/Engineer. Please ONLY local candidates to Summit NJ. Work Schedule: Wed-Sat- (7am-5pm) EST. MUST have 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. MUST have relevant work experience, preferably in a health authority regulated environment.

Work Location: Summit NJ

Pay: $46-48/hour W2

Required Skills:

Responsible for leading 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

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

Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory

Management system) or Infinity

Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality

Control

Requires a Bachelors Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred)

Previous experience working in a biopharmaceutical manufacturing

facility is preferred (CAR T a plus)

Conduct thorough investigations (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

May travel between NJ sites for training, meetings or corporate events on

occasion

Will need to have flexibility to work extended hours (>8 hours/day),

weekend and/or holidays when required to meet deadlines