Sr Process Validation Engineer
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Grand Rapids, MI 49504
Description:
Roles & Responsibilities:
- Lead process validation projects of broad scope.
- Collaborate with clients, Validation, and cross-functional 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 execution 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 execution 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 multi-shift 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).
- Candidate must have significant Pharma/Biotech process validation and PPQ experience. Cannot just be knowledge of.. MUST HAVE the hands on experience doing. If they have it but it's not prevalent in the resume please have them provide a detailed summary of applicable experience.
- Lead process validation efforts for parenteral drug product manufacturing and finishing processes. Coordinate, execute, and oversee process performance qualification (PPQ) activities with cross functional project teams. Represent Validation in client interactions. Generate validation deliverables.