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Process Development Engineer
3 weeks ago
We are seeking an experienced Process Engineer to join our team as a Technical Support Manager. In this role, you will provide technical expertise to support new product introduction (NPI) and commercial manufacturing.
You will work closely with cross-functional teams and liaise with vendors or above-site groups to ensure smooth project execution.
Familiarity with process monitoring systems, automation systems (DeltaV), and operational intelligence & data systems (Pi System) within a GMP manufacturing environment is desirable but not required.
Responsibilities- Develop and implement qualification/validation documentation and process development studies.
- Design and develop change controls.
- Author and review quality notifications.
- Implement equipment/qualification validation programs.
- Support continuous improvement initiatives.
- Analyze system failures and resolve issues.
- Represent technical operations at global technical forums.
- Ensure compliance with regulatory requirements and cGMP.
- Manage stakeholder relationships.
