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Sr. Process Engineer, Manufacturing Technical Support (Aseptic Operations)

Company: Pacira BioSciences
Location: San Diego
Posted on: February 23, 2021

Job Description:

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. Pacira--BioSciences currently has an opening for a Sr. Process Engineer, Manufacturing Technical Support (Aseptic Operations).The successful Process Engineer will be responsible for providing technical support and project support to Operations, Facilities, Research and Development, Quality, and Regulatory Affairs. This position will focus primarily on two areas- (1) optimization of process operations, providing support in areas such as data analysis identification of potential process bottlenecks and vulnerabilities, investigations into process abnormalities, and troubleshooting for EXPAREL Bulk and aseptic filling operations, and (2) capital project support from the design, commissioning, and implementation. This position will require knowledge of cGMPs and experience with GMP manufacturing.Responsibilities:* Identify and rectify process and equipment bottlenecks* Serve as an internal primary subject matter expert for aseptic filling operations* Act as a technical lead for new projects for aseptic filling from the design perspective* Lead/Support complex sustaining engineering projects* Participate in troubleshooting and start-up of Bulk and Filling Process Equipment* Provide on-call support for Operations on an as needed basis* Provide technical input for solutions to increase throughput* Participate in cross functional teams dedicated to process improvement, efficiency, and optimization* Provide technical assessments for investigations, validation, and change control* Lead corrective actions as a result of investigations* Generate and revise control documents to support process equipment and manufacturing processes* Participate in technology transfer within the company and to partners* Support GMP audits from regulatory agencies as well as internal audits* Provide support as a subject matter expert for capital projects from concept, funding design, and transfer to internal clients Qualifications:* Bachelor's degree in Chemical Engineering or Mechanical Engineering Degree from an accredited college or university* Minimum 7 years of experience in pharmaceutical environment* Extensive experience in the support of aseptic operations* Extensive cross-functional team experience, including technical and non-technical work* Recognized as a technical expert by peers and other personnel within the business unit* Successful track record of project execution * Proven ability to lead projects.* Possesses a high level of technical expertise on CIP/ SIP and equipment design* Ability to organize and present technical and project mgt. overviews to upper management and executives.* Technically independent and maintains state-of-the-art technical abilities. Display initiative and commitment.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.

Keywords: Pacira BioSciences, San Diego , Sr. Process Engineer, Manufacturing Technical Support (Aseptic Operations), Engineering , San Diego, California

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