Sr. Process Engineer

4 weeks ago

Boca Raton, United States ADMA BIOMANUFACTURING LLC Full time

Job DetailsLevelExperiencedJob LocationADMA Biologics - Boca Raton, FLPosition TypeFull TimeDescriptionADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Senior Process Engineer in Boca Raton, FLThe Senior Process Engineer provides process engineering, project engineering and maintenance support to the Manufacturing Facility. Develop and establish maintenance/engineering tools/programs to ensure that the facility is kept in a good state of repairs as well as all process equipment are cGMP compliant from a facility, maintenance and engineering perspective. Direct, evaluate and assist capital engineering and process improvement projects. Facilitate requisitions or equipment and parts. Serve as equipment/facility expert and interface with regulatory agencies on audits etc. Must have the ability to apply engineering theory, practices and principles to determine root cause of equipment failures and to perform equipment performance evaluations.QualificationsManage individual engineering projects by planning and tracking activities of cross-functional teams and contractors. Develop schedules and performance requirements using appropriate verification tools and techniques to manage project scope, schedule and cost ensuring that project goals are met on time and within budget.Facilitate engineering projects using the Stage Gate approach from feasibility to project close-out. Measure project performance using appropriate systems, tools and techniques, evaluate appropriate sources for project information and dissemination of information as appropriate to relevant employees and outside partners. Analyze resources and priorities to be applied to assigned projects and perform risk management activities to minimize project risks.Direct and or assist in the design and execution of all capital projects assigned.Support project development with load calculations of flow, cooling capacity, heating capacity, pressures, etc.Provide process engineering support for required equipment upgrades and or modifications and champion these efforts including writing and directing all change control activities/ deviations as required by our Quality Systems, OSHA etc.Perform design reviews and create design review reports.Investigate and, where possible, devise /implement plans to eliminate any mechanical or maintenance problem which would affect production and work towards successful resolution.Help develop efficient PM plans for all key pieces of manufacturing equipment etc. and provide troubleshooting expertise in all areas of plant operations and maintenance. Provide process engineering support for required equipment upgrades and or modifications and champion these efforts including writing and directing all change control activities/ deviations as required by our Quality Systems, OSHA etc.Assist in and or champion investigation of deviations that are facilities/maintenance related, Train SMEs in problem solving techniques and ensure the appropriate corrective actions are taken. Use statistical tools in analyzing data to predict trends, measure process capability, improve operating procedures or preventative maintenance procedures, identify bottle necks, and equipment reliability.Asist in writing regulatory documents for FDA submission as required.Continuously monitor the manufacturing operation to look for process optimization /debottlenecking opportunities and make technical engineering recommendations/changes as deemed necessary.Serve as the technical liaison for all OSHA, regulatory and other audits that relate to the maintenance/facility aspects of the manufacturing facility.Create capital expenditure requests, purchase requisitions and submit for approval.Train Process Engineers in ADMA Manufacturing processes and utility systems.Prepare annual evaluation and operational assessment reports of critical systems and equipment for review and final approval.Education Requirement: Bachelor's degree in Mechanical, Biochemical, or Chemical Engineering.Experience Requirement: Five years solid process engineering/project engineering experience in a cGMP, Pharmaceutical/Biological manufacturing environment.In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vestingMedical, Vision, Life and Dental InsurancePet Insurance Company paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail stationADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify. ADMA Biologics is an Equal Opportunity Employer.

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