Process Engineering Specialist
1 week ago
**About Us**
Psc Biotech Ltd is a leading biotechnology consultancy firm that has been driving innovation in the industry since 1996. Our global operations span across multiple countries, and we have successfully served over 350 clients worldwide.
We provide cutting-edge software solutions for quality management and regulatory inspections, catering to the needs of pharmaceutical contract manufacturing professionals and metrology services. Our Employee Value Proposition (EVP) sets us apart from the conventional consultancy model, offering unparalleled career development opportunities through our in-house training and mentorship programs.
As a Psc Biotech employee, you will have the chance to work with top pharmaceutical client sites in a diverse cultural setting. We believe in creating high-performing teams that exceed our clients' expectations in terms of quality, scalability, and business unit deliverables.
Role Description:
As a Process Engineering Specialist, you will be responsible for providing process technical and validation support to operations for commercial manufacturing and process simulation development and execution. This includes coordinating designing and executing commercial and process simulations studies as required.
You will serve as technical support for manufacturing and new product introduction, design author review approve and execute process simulations studies, and provide technical input into quality notifications by authoring reviewing approving process simulation related investigations.
- Design Author Review Approve Execute Commercial and Process Simulation Qualification Validation Documentation and Studies
- Provide Technical Input into Quality Notifications
- Serve as Technical Support for Manufacturing and New Product Introduction
Key Responsibilities:
- Perform root cause analysis of system failures using standard tools and methods
- Implement subsequent corrective action through the change management system
- Participate and/or lead cross-functional or single-function teams
- Drive compliance of client Global Policies Procedures and Guidelines regulatory requirements and execute current Good Manufacturing Practices cGMP
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