Job Description

About Precision NanoSystems Inc. (PNI)

PNI is a global leader in ushering in the next wave of genetic medicines in infectious diseases, cancer and rare diseases. We work with the world's leading drug researchers to understand disease and create the therapeutics and vaccines that will define the future of medicine. PNI offers proprietary technology platforms and comprehensive expertise to enable researchers to translate disease biology insights into non-viral genetic medicines.

Position Summary

The Senior Process Engineer will be responsible for setting up, documenting, and maintaining processes and process equipment for PNI's pharmaceutical production lines. The selected candidate will report to the Director of Engineering with a dotted line to the Director of Clinical Manufacturing and work with hardware engineering, formulation teams, tech dev, quality and manufacturing operations to ensure a smooth production ramp-up and steady-state production. The Senior Process Engineer will review and optimize process parameters based on a risk analyses and experimental design, select and set-up equipment, document processes, equipment setup and maintenance procedures, support production escalations, and participate in new product development.

The ideal candidate will have a chemical engineering degree or equivalent and have experience with setup and operation of production lines for pharmaceutical grade drugs or excipients.

Areas of Responsibility

• Development and documentation of production processes, best practices, and policies
• Prepare standard operating procedures (SOPs), specifications, qualification protocols and reports for Production equipment
• Setup and maintenance of production equipment, and perform training where applicable
• Address production deviations and escalations
• Support the creation and revision of Drug Product Master Batch Records
• Process review and de-risk (e.g. PFMEAs, DFM, determining critical parameters, determining process limits, etc.)
• Production monitoring and metrics (e.g. monitoring and record keeping of critical parameters)
• Audit preparation and readiness
• Assist with the technology transfer of nanoparticle manufacturing equipment and processes to GMP manufacturing sites
• Perform other duties as assigned.

Qualifications and Experience

• Bachelor's Degree in Chemical Engineering, Life Sciences or equivalent
• Minimum 10 years of experience in pharmaceutical in drug product manufacturing or equivalent regulated environment
• Understanding of and fluent in hardware specification and setup and chemical process development
• The individual must be a team player who thrives in a dynamic environment with challenging timelines.
• An excellent communicator (verbal and written), with strong organizational, and time-management skills.
• A proven ability to troubleshoot and solve complex technical issues.
• An ideal candidate is committed to developing their technical skills while contributing to PNI's internal and partnered development programs.

PNI provides a competitive compensation and benefits package with excellent opportunities for personal growth.

Only candidates selected for an interview will be contacted. Posting valid until filled. No solicitors please.

Precision NanoSystems, Inc. is an equal opportunity employer.