Process Engineer
2 weeks ago
This is a remote position with a focus on sterile drug product technical transfers.
Key Responsibilities- Design process development studies based on direction from Drug Product Tech Transfer Lead
- Author and review study protocols
- Support planning & execution of full-scale process development, engineering, or qualification batches
- Lead data collection, analysis, and report writing
- Second-person review of technical documents
- Change control support for technical transfers
- Change control support and/or data analysis support for commercial drug product production based on business needs
- Solid technical writing skills (protocols, reports)
- Able to execute a study protocol following cGMPs
- Able to perform data analysis (statistical analysis using JMP)
- Able to work independently and deliver results, under oversight of Tech Transfer Lead
- Able to adapt to changes in work priorities (e.g. shift between projects)
- Experience in sterile drug product technical transfers
- Experience with commercial manufacturing of sterile drug product
- Experience with sterile manufacturing processes (environmental controls, aseptic techniques)
- Change Control authoring, management, support
Location: Remote with 25% Travel. All travel expenses are paid
Pay Range: $110/Hr
Job Type: Contract 12-18 Months
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