Process Development Engineer 3 (Product Development)

Research & Development San Diego, CA


Description

About Pacira

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.

 

Why work with us?

Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.  At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.

 

Summary

The purpose of this position is to actively participate in the development of pharmaceutical processes, scale-up, aseptic process validations, manufacturing facility technology transfers, and commercial launch of sterile production manufacturing facilities. Also responsible for manufacturing processes and equipment investigations as well as provide recommendations for integration and commercialization of new processes.

 

Essential Duties and Responsibilities:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

 

  1. Trouble-shoot problems that come up during all stages of process development, including clinical and commercial manufacture of sterile injectable drugs.
  2. Document work, summarize findings and present data.
  3. Hands on work to set-up and run experiments on clinical and commercial scale manufacturing equipment.
  4. Provide technical support to other groups including Formulation Development, Analytical Research and Development, Manufacturing, Validation, and QA.
  5. Work in laboratory and GMP manufacturing settings.
  6. Participate in the process development and production of DepoFoam products.
  7. Design and scale-up processes to commercial scales.
  8. Perform factory acceptance testing for new equipment, commissioning, and assist with Validation of new processes as needed.
  9. Participate in pre-commercial manufacturing facility activities (mechanical commissioning, operational commissioning, software testing, aseptic process simulations, SIP qualification, etc.)
  10. Drive individual projects and demonstrate skill set beyond that of an Engineer II.

 

 Education and Experience:

  • BS in Chemical Engineering, Pharmaceutical Chemistry, or Equivalent
  • Preferably 5-8 years of pharmaceutical and/or R&D experience
  • Ability to design and conduct design review of new manufacturing equipment.
  • Ability to manage multiple responsibilities with a high degree of self-motivation.
  • Experience with aseptic processing, SIP, and CIP is required.
  • Knowledge of cGMPs and experimental design required.
  • Hands on lab, pilot plant, or commercial production experience.
  • Knowledge of process equipment and chemistry is required.
  • Ability to work both independently and in cross functional teams.
  • Demonstrated computer efficiency (e.g., word processing, spreadsheets).
  • Ability to read P&IDs.
  • Excellent observation skills and problem solving ability.
  • Proficient oral, written, and interpersonal communication skills.  

 

 

EEO Statement

Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.