Process Development Engineer 2

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. We are currently seeking an Engineer 2 located in San Diego, CA.

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 launch of sterile production manufacturing facilities.

Responsibilities:

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

Qualifications:

• BS in Chemical Engineering or Equivalent
• Preferably 3-5 years of pharmaceutical and/or R&D experience
• Ability to manage multiple responsibilities with a high degree of self-motivation.
• Experience with aseptic processing, SIP steam sterilization, and CIP.
• Experience with high potent products is preferred.
• Knowledge of cGMPs and experimental design.
• 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).
• Strong observation skills and problem solving ability.
• Excellent communication skills (oral and written).

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.