Process Engineer II at CSL Plasma Process Engineer II at CSL Plasma in holly springs, North Carolina Posted in 2 days ago. 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.

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 Qualifications:

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 Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.