Process Engineer II

CSL; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

CSL in Holly Springs, NC is seeking a Process Engineer to support the Filling area on-site, Monday–Friday, with an on-call rotation. You will report to the Sr. Manager Processing Engineering Fill Finish and help sustain operations and equipment in the area.

Qualifications include a engineering degree and 3+ years in pharmaceutical manufacturing or quality assurance, plus strong knowledge of cGMPs and FDA/EPA/OSHA requirements. Experience with project management and lifecycle phases is desirable.

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.

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

Skills

Pharmaceutical manufacturing

Regulatory compliance

Project management

cGMP knowledge

Education

MS/MBA/BS/BA in Engineering, Business Administration or Life Sciences preferred

Job description

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.