Process Development Engineer II

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, equipment design, manufacturing technology transfers, and clinical/commercial launch of sterile production manufacturing facilities.

 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 manufacture of sterile injectable drugs.
  2. Hands on work to set-up and run experiments on clinical and commercial scale aseptic manufacturing equipment.
  3. Provide technical support to other groups including Automation, Operations, Validation, and QA.
  4. Lead and participate in troubleshooting and start-up of Process Equipment.
  5. Provide technical assessments for investigations, validation, and change controls. Manage corrective actions as a result of investigations.
  6. Participate in technology transfer.
  7. Work in laboratory, commercial manufacturing, and clinical manufacturing settings.
  8. Participate in the process development and production of new pipeline products.
  9. Support design and scale-up of clinical processes to commercial scales.
  10. Execute Validation of new processes as needed.
  11. Participate in pre-commercial manufacturing facility activities (mechanical commissioning, operational commissioning, software testing, aseptic process simulations, SIP qualification, etc.)

 Education and Experience:

  • BS in Chemical Engineering or Equivalent
  • Preferably 3-5 years of pharmaceutical and/or R&D experience

 Knowledge, Skills, and Abilities:

  1. Ability to manage multiple responsibilities with a high degree of self-motivation.
  2. Process development experience is preferred.
  3. Experience with aseptic processing, SIP steam sterilization, and CIP.
  4. Experience with high potent products is preferred.
  5. Knowledge of cGMPs and experimental design.
  6. Hands on lab, pilot plant, or commercial production experience.
  7. Knowledge of process equipment and chemistry is required.
  8. Ability to work both independently and in cross functional teams.
  9. Demonstrated computer efficiency (e.g., word processing, spreadsheets).
  10. Strong observation skills and problem-solving ability.
  11. Excellent communication skills (oral and written).  

 

Clean rooms, manufacturing facilities, equipment production facilities, laboratories, offices, and cubicles.

 Travel:

Must be able to travel up to 5% 

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.

 

At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.