Sr Process Validation Engineer
Sr Process Validation Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Must have significant Pharma/Biotech process validation and PPQ experience.
- Lead process validation projects of broad scope.
- Collaborate with clients Validation and crossfunctional team members to coordinate projects resolve issues and meet aggressive timelines.
- Represent Validation in customer interactions and communicate customer requirements to the broader Validation team as needed.
- Oversee of process validation (PPQ) protocols on the production floor on varying shifts as needed to ensure that protocol requirements are satisfied.
- Effectively manage multiple high priority validation projects effectively.
- Responsible for project deliverables such as VMPs pFMEAs PPQ protocols and reports change control assessments technical transfer assessments as well as other client deliverables as required.
- Provide training for internal customers on protocol requirements and responsibilities.
- Provide technical support to Manufacturing troubleshooting and resolving process related issues.
- Participate in investigations and provide documentation for Deviations and CAPA based on OOS/OOT results or validation activities.
- Open to a flexible and fluid work environment with schedule flexibility to support multishift operations.
- Perform all job responsibilities in compliance with applicable regulations standard operating procedures and industry practices. Support Agency customer and vendor audits as a validation subject matter expert (SME).
Employment Type
Full Time
