Engineer Validation and Automation


Job ID 19-00025

Industry Pharma

Job Type Permanent

Location East Windsor, NJ

Description

- Document and execute equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment and end-of-line processes
- Provide Technical support required to ensure that the packaging lines are compliant as per the DSCSA Serialization requirements
- Interface with customers on technical issues, project timeline, and validation support
- Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations
- Experience of developing /configuring Electronic Batch Records (EBR)
- BS or MS in Engineering, Life Sciences, IT, or equivalent
- Minimum of 2-5 years' experience in a highly automated biotechnology or pharmaceutical manufacturing environment
- Understanding of pharmaceutical / biotechnology processes and experience in a cGMP environment
- Knowledge of CSV,FDA and GMP guidelines a must
- Strong knowledge of supply chain management and/or manufacturing processes, having the ability to implement strategies to improve the efficiency of the process



Qualifications