10450 Science Center Drive
San Diego, CA 92121
(858) 625 2424
5 Sylvan Way
Parsippany, NJ 07054
(973) 254 3560
Pacira provides outstanding career opportunities for innovative and motivated team players who are committed to making a difference. We are excited about your interest in employment with Pacira. Our need for talented and team oriented people will continue to grow with our product development and collaborative programs.
Pacira is an equal opportunity employer. We respect individual differences, embrace diversity throughout the organization, and value the unique strengths of each employee.
To be considered as an applicant, please submit your resume or CV referencing the specific position of interest and position code to careers@pacira.com. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions.
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The purpose of this position is to assure that all operations within Pacira are in compliance with current Good Manufacturing Practice (cGMP) and applicable state, federal, or international regulations as well as internal policies and procedures. Responsibilities for this position include but are not limited to: Responsibility for all support investigations for Incident Reports for Manufacturing, QC/Micro out-of-specification and out-of-trend test results, Facilities out-of-limits reports, Calibration out-of-tolerance notifications, environmental monitoring action reports, temperature excursions, non-conforming material reports and batch failure investigations; Propose and approve CAPAs; Investigate and respond to Product Complaints; Proactively participate and Direct Batch Failure Investigations; and, Review and approve all Standard Operating Procedures (SOPs), Engineering/Software Change Requests, Validation Protocols/Reports, and Engineering Drawings. In addition, Perform and monitor inspection of labeled vials for accuracy, correctness, and legibility and assist in the review of documents and data submitted in or in support of regulatory submissions. Will also be responsible for maintaining QA control of raw material quarantine and raw material reserve samples. Ideal candidate will have a BS Degree in Chemistry and 10 years of relevant Pharmaceutical Industry experience. Qualifications also include: Substantive knowledge of cGMPs, EMEA and MHRA regulations and their application; which includes hosting those regulatory agencies general audits. Experience in decision processes, problem solving, root cause analysis and constructive issue resolution, and the ability to work successfully in a fast-paced, rapidly changing environment.
The purpose of this position is to assist in a design and scale-up of complex aseptic pharmaceutical processes from pilot to commercial scales. In addition position will provide technical support and leadership in process characterization work, product manufacturing and process/equipment validation efforts. Work hands-on in the lab, pilot plant and commercial facilities to set-up, develop and perform experiments challenging process parameters to characterize processes. The ideal candidate will have a BS degree in Chemical/Biochemical Engineering or Chemistry and the knowledge of bioprocess equipment design and process chemistry. Some experience with aseptic processing, CIP, and equipment design is a plus. The ability to manage multiple responsibilities with a high degree of self-motivation as well as the ability to work both independently and as part of a team is critical.
This position will be responsible for providing process and equipment engineering capabilities and experience to the Process Equipment group in the Product Development and Technology Transfer department. Efforts of the Process Equipment group focus on the design and scale-up of new manufacturing equipment, monitoring procurement activities and equipment fabrication, factory acceptance testing, site installation, site acceptance testing, start-up, and validation. Incumbent is expected to work independently and use judgment in carrying out functions. Knowledge and experience working under cGMPs and strong applied problem solving skills are essential. Incumbent will provide process engineering design support services for the scale-up and commercialization of new products, work with design drawings including PFDs, UFDs, and P&IDs, work with and/or supervise external engineering consultants, and review drawings and documents produced by support groups. The incumbent will also provide key input into validation of process equipment and associated utilities, including the generation of validation plans and protocols, and providing direction for manufacturing and operations staff in the execution of validation protocols. The ideal candidate will have a Bachelor of Science degree in engineering (Chemical or Biochemical preferred) and from 2 to 5 years of applicable equipment, clean utility, process system, and process control experience in the pharmaceutical/biotech industry. Experience related to sanitary and sterile operations is a significant benefit.
The purpose of this position is to carry out assigned laboratory duties which may include sampling, testing, and evaluating analytical data on samples such as raw materials, in-process and final products. Incumbent will be responsible for the following; Conduct laboratory tests in compliance with established Standard Test Methods and within regulatory and laboratory requirements; Assist in the development and improvement of written procedures and protocols. Maintain organized records of tests performed and results obtained. This may include maintaining a computer accessible database for the purpose of tracking and trending analytical data; Assist in performing laboratory investigations; and, Write investigation report as required. Requirements include 2 years of relevant hands-on laboratory experience and a BS degree in scientific discipline or equivalent experience. Ideal candidate will have: Demonstrated computer proficiency, e.g., word processing, spreadsheets, graphing, etc; Good knowledge of cGMPs and laboratory practices; and, Proficient in the operation and maintenance of basic laboratory instruments and at least two major ones such as HPLC and GC.
The purpose of this position is to ensure that manufacturing systems and support utilities to include autoclaves, Glass Washers, Fill Line, WFI, Clean Steam are maintained per SOP and available to meet the manufacturing schedule. This includes maintaining the physical operation of the systems as well as their documented state ensure; and, assisting in the validation of new or modified Equipment and Systems. The ideal candidate will have 4 years of relevant facilities equipment experience as well as a High School Diploma or equivalent education. Must have: technical skills in HVAC, aseptic processing, clean rooms and clean; knowledge of cGMP parenteral manufacturing practices and facilities and a significant knowledge of cGMP pharmaceutical manufacturing support utilities; the ability to manage projects with a high degree of self-motivation; and, knowledge of cGMP record keeping and documentation practices.
The purpose of this position is to assist in the development and maintenance of global systems for managing the collection, evaluation, and reporting of all spontaneous adverse event reports and clinical study adverse event reports related to Pacira Pharmaceuticals’ marketed and investigational products. Will be responsible for providing oversight and supervision of the receipt, processing, assessment, coding, reporting, and archiving of all spontaneous AE reports and clinical study SAE reports worldwide; Operating and maintaining the Oracle Adverse Event Reporting System (Oracle AERS) for the capture, follow-up and regulatory reporting of clinical safety data relating to investigational and marketed products; and Facilitating prompt and complete follow-up and review for all reported adverse events. In addition, will maintain and update processes for submitting paper Expedited Reports and electronic individual case safety reports; provide oversight and supervision regarding the content of PSUR safety sections and Clinical Study Annual Reports; and, establish procedures and cooperate with domestic and foreign corporate marketing partners regarding the exchange of AE information and the reporting of AEs to international regulatory agencies. Ideal candidate will have a Bachelor’s degree in nursing or equivalent experience and five (5) years of relevant clinical nursing/pharmacy experience. Will also need demonstrable experience with the processing, evaluation and reporting of clinical safety data for both investigational and marketed products in the biopharmaceutical industry; familiarity with adverse event coding systems (e.g. MedDRA, WHO, ICD); experience with at least one commercially available adverse event database software; and, must have a working knowledge of US and International regulatory requirements for safety reporting for both investigational and marketed products. Specific knowledge in US and EU safety regulations is required. Travel will be required.
Note to Recruiters: Pacira does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Pacira from recruiters do not constitute any type of relationship between the recruiter and Pacira and do not obligate Pacira to pay fees if we hire from those resumes.