- Title: Engineering - Process Engineer
- Code: RCI-30760-1
- Location: New Brunswick New Jersey (NJ) 08903
- Posted Date: 03/09/2020
- Duration: 12 Months
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- Name:Pramod Rajput
- Email: Pramod.firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 217
- Provide technical support to the External Manufacturing Organization and assigned contract manufacturing organizations (CMO's), ensuring the transfer of robust manufacturing and packaging processes to CMO's and/or Client sites.
- Ensure continuity of supply from assigned CMO's and support ExM projects and objectives.
- Responsible for personal, colleague, and workplace safety.
- Provide input to ExM MT colleagues for potential OpEx projects; assist with project execution and completion.
- Assist ExM MT with product robustness efforts and resulting projects and initiatives.
- Represent ExM MT and work closely with the SRM, Quality, and other team members in developing and executing projects, strategies, and OpEx problem- solving efforts.
- Track CMO investigations and CAPAs from inception to completion; assist ExM MT staff as necessary in problem resolution.
- Gather information as needed from the CMO for product transfer, investigation / CAPA, or other MT projects and initiatives.
- Supports efforts to meet / exceed ExM MT objectives.
- Ability to assist / lead the process to successfully complete investigations and related CAPAs.
- Knowledge of OSD manufacturing and/or packaging operations, including but not limited to knowledge of cGMPs, validation, and quality systems.
- Bachelor’s degree or higher in a scientific discipline, preferably an engineering or pharmacy degree.
- Prior experience in the pharmaceutical industry, preferably in MT, Packaging Technology (PT), OSD manufacturing, and/or OSD packaging.
- Basic regulatory knowledge, particularly with respect to the transfer of manufacturing and/or packaging operations.
- Ability to effectively communicate orally and in writing;