Process Engineer II

Virtual Company; Branchburg Township (NJ); On-site; USD 85,000 - 110,000; Full time

Job summary

The Fountain Group is seeking a Process Engineer II to provide 1st shift engineering production support at our New Jersey site in Branchburg Township. You will assist on-floor to implement process improvements and support manufacturing operations.

You will collect and analyze data on quality, cost and speed to market, investigate non-conformances, drive CAPAs, and assess change orders and supplier change requests, initiating and following through change control processes to ensure compliant

Qualifications

• BS in Engineering, Science, or closely related discipline with 2-3 years pharma or related experience.
• Experience with Cleaning Validation, Process Validation and Process Monitoring.
• Experience with IQ/OQ/PQ for equipment qualifications.
• Knowledgeable with One-Vault, TrackWise, Microsoft PowerPoint and Statistical Software.

Responsibilities

• Provide 1st shift engineering production support on the floor.
• Implement process and technology improvements.
• Collect, monitor, analyzing, troubleshooting, and reporting manufacturing data related to quality, cost, and speed to market.
• Investigate non-conformances, CAPAs, process performance drifts and implement corrective and preventative actions.
• Conduct technical assessments of change orders and Supplier Change Requests.
• Initiate and follow-through of the change control processes.

Education

BS in Engineering/Science or closely related discipline

Tools

One-Vault

TrackWise

Microsoft PowerPoint

Statistical Software

Job description

The Process Engineer II is responsible for providing 1st shift engineering production support including:

• Implementing process and technology improvements
• Regular on-the-floor manufacturing support
• Collecting, monitoring, analyzing, troubleshooting, and reporting manufacturing data related to performance in the areas of quality, cost, and speed/service to market
• Investigating non-conformances, CAPAs, process performance drifts and implementing corrective and preventative actions
• Conducting Technical assessments of change orders and Supplier Change Requests
• Responsible for the initiation and follow-through of the change control processes

Qualifications:

• BS of Engineering, Science, or closely related discipline w/ 2-3 yrs experience in Pharmaceutical or related
• Experience with Cleaning Validation, Process Validation and Process Monitoring
• Experience with IQ/OQ/PQ for equipment qualifications
• Knowledgeable with One-Vault, TrackWise, Microsoft PowerPoint and Statistical Software

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