Sr. Process Engineer, Manufacturing Technical Support (Aseptic Operations)
Company: Pacira BioSciences
Location: San Diego
Posted on: February 23, 2021
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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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