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Technical Operations Scientists (2 openings)-3096130719
Janssen Ortho LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Technical Operations Scientist (2 positions) for the facility located in Gurabo, Puerto Rico.
Janssen Ortho LLC., provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologic (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
The Technical Operations Scientist is responsible to provide technical support for implementation of technical projects related to: Products transfer, process improvement, cost improvement and validations. Conduct technical assessments and investigations related to process discrepancies, data trending, and complaints. The incumbent will work with minimal supervision and guidance and will perform these activities as a productive member of Project Teams and in some cases as Project Leader. Should be able to run independent projects and represent the technical group on cross-functional teams. Design, execute and implement technical projects with minimal guidance. These projects can include: product characterization, minor reformulations, validations, line extensions, CIPs and process improvement projects. Investigate and troubleshoot product deviations and production trending using technical and scientific skills. Identify corrective actions and institute these corrective actions. Coordinate department support for activities/documentation of other area projects on which this person is a team member. Write and develop department SOP and Master Plans. Write and review technical documents within and outside the group such as: Technology Transfer Strategy, Characterization Protocols/Reports, Risk Assessments, Technical Investigations, APR's, Technical Assessments, FMEA's, among others.
A minimum of a Bachelor Degree in Chemistry, Pharmacy, Chemical Engineering or related Science or Engineering is required. A Master Degree in Science or Engineering is desired. Minimum three (3) years of overall experience within the pharmaceutical industry as a Technical Team Scientist, and at least one (1) year of experience within Process Development in the solid dosage sector (technical environment), is required. Knowledge of technical support writing, cGMP's, FDA regulations, solid dosage technology, pharmaceutical/formulation process, pharmaceutical manufacturing equipment and validation/qualification is required. The incumbent must be a computer literate (MS Office applications and Internet). SAP and ELab knowledge is preferred. Good communication, organizational, interpersonal and influencing skills. Excellent oral and written communication skills in English and Spanish are required. The incumbent will have to work effectively and collaboratively with a broad cross section of functional areas. Must be a critical thinker with problem solving skills. Ability to make decisions after the initial requirements are set and take actions that may be difficult or complex. This position requires to constantly performing tasks inside an office and inside manufacturing rooms, and the ability to work different shifts, overtime hours, and weekends when required. Availability to travel outside Puerto Rico when required (20% of the time).
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Primary Location: North America-United States-Puerto Rico-Gurabo
Organization: Janssen Ortho LLC (2162)
Job : R&D
Relocation: Eligible No
Travel: Yes, 25 % of the Time
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