Process / Validation Engineer

Position Title : Process / Validation Engineer

Work Location : Branchburg, NJ 08876

Assignment Duration : 09 months

Summary :

The Process / Validation Engineer is responsible for providing engineering production support including :

• Implementing process and technology improvements
• Process and Cleaning Validation
• Equipment Qualification
• 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
• Responsible for the initiation and follow-through of the change control processes.

Education and Experience

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

Preferred Skills

What are the top 3-5 skills, experience or education required for this position :

1. Process and Cleaning Validation Experience

2. Equipment Qualification (IOQ / PQ)

3. Quality System Experience (Veeva, Trackwise, ComplianceWire)

4. Medical Device or Pharmaceutical Experience Required. Preferred Medical Device with 3-5 Years

5. Statistical Analysis (Minitab or JUMP)