Process Engineer II
Seqirus•Holly Springs, NC
•Onsite
About The Position
This position will be for a M-F ~8am-5pm Position supporting the Filling area. This position requires on site work in Holly Springs, NC and will involve supporting an on-call rotation. The position will report to the Sr. Manager Processing Engineering Fill Finish and work to support operations and equipment in the area.
Requirements
- MS/MBA/BS/BA in Engineering, Business Administration or Life Sciences preferred
- 3+ years practical experience in pharmaceutical industry in Manufacturing, Engineering or Quality Assurance
- Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
- Understanding of project management principles and project lifecycle phases.
- Knowledge of Validation, CMC and facility regulatory submission requirements
Responsibilities
- Works independently with general supervision in carrying out assigned process-related improvement projects in compliance with safety and regulatory requirements during all phases of assigned projects
- Manages from concept and scoping phase, design, preparation of specifications, appropriation requests, through to procurement, installation and start up phases for capital, expense and lease additions to a facility
- Assures compliance with FDA, EPA, and OSHA requirements during all phases of assigned projects
- System ownership of PFS high speed filling line
- Support deviation investigations and interface with equipment owners and stakeholders
- Owns Actions in Trackwise change management system
- Maintains Documents in Veeva GDocP System
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
