Sr. Process Engineer

PCI Pharma Services•San Diego, CA

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. SUMMARY: Design and optimize pharmaceutical and biopharmaceutical manufacturing processes for improved efficiency and yield. Supports manufacturing operations and mentor junior engineers. Lead technical assessment and improvement/scale up projects for manufacturing processes, including managing projects through to successful completion.

Requirements

Bachelor's degree required (Bioengineering, ChE, EE, IE, ME, or similar) or Exceptions for equivalent work experience
Minimum eight (8) years of relevant experience
Minimum six (6) years of cGMP experience
Advanced knowledge of manufacturing processes
Mastery of process flow and troubleshooting
Advanced understanding of GMP regulations and requirements

Responsibilities

Design and specify processes and manufacturing equipment systems
Evaluate existing systems for continuous improvement
Provide in-depth technical review of all documents
Research new technologies and implement new/upgraded systems
Document changes to systems per change management procedures
Travel between facilities to support all manufacturing processes
Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.