BioSpace
Overview
ADMA Biologics is a biopharmaceutical company dedicated to creating superior products for immunodeficient patients at risk for infection. We currently have an exciting opportunity for a Senior Project Engineer in Boca Raton, FL. Job Title
Senior Project Engineer Responsibilities
Managing mid-to-large sized engineering projects by planning and tracking activities of cross-functional teams and contractors. Develop schedules and performance requirements using verification tools and techniques to manage project scope, schedule and cost, ensuring project goals are met on time and within budget. Analyze resources and priorities and perform risk management to minimize project risks. Develop and execute commissioning plans to ensure that process and utility systems and equipment are suitable for their intended use Develop and review process flow diagrams and P&IDs for new process and utility systems and modifications to existing systems Direct or assist in the design and execution of all capital projects assigned Support engineering development with load calculations of flow, heating/cooling capacity, pressures, etc. Prepare engineering evaluations, change control documentation, testing plans, CAPAs using strong technical writing skills Lead and assist in investigations of process systems and equipment to determine root cause and ensure corrective actions are initiated and implemented; use statistical tools to analyze data, predict trends, measure process capability, improve procedures, identify bottlenecks and equipment reliability Develop efficient preventive maintenance plans for key manufacturing and utilities equipment and provide troubleshooting expertise across operations and maintenance Serve as the technical liaison for OSHA, regulatory and other audits related to maintenance and facility aspects of the site Assist in writing regulatory documents for FDA submissions as required Create capital expenditure requests and purchase requisitions for approvals prior to procurement of process and utility systems and equipment Qualifications and Experience
Ability to follow cGMPs and procedures with great attention to detail Ability to read and understand blueprints Ability to evaluate and interpret regulations and recognize the need for changes to procedures Ability to work in a high-pressure, deadline-driven environment Provides feedback to operations management and staff regarding performance against SOPs; fosters collaborative relationships with operations management Advanced knowledge of standard office software (Microsoft Word, Excel, and Project) Excellent problem-solving and analytical skills; able to frame issues for non-technical colleagues Exceptional organizational and communication skills Good mechanical aptitude and knowledge of general maintenance Identifies ways to improve workflow and efficiencies within SOP constraints Excellent writing and verbal communication skills; able to translate technical concepts to both senior management and frontline staff Time management skills and ability to balance multiple assignments Experience
Minimum of 10 years of engineering experience in a cGMP Pharmaceutical/Biological manufacturing environment Benefits and Compliance
Comprehensive benefits package including 401K with employer match and immediate vesting; Medical, Vision, Life and Dental Insurance; Pet Insurance Company-paid STD and LTD; Company Paid Holidays; 3 Weeks’ Paid Time Off (within the first year) Tuition Assistance (after the first year) Easy access to Tri-Rail; Free shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm employment eligibility ADMA Biologics is an Equal Opportunity Employer
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ADMA Biologics is a biopharmaceutical company dedicated to creating superior products for immunodeficient patients at risk for infection. We currently have an exciting opportunity for a Senior Project Engineer in Boca Raton, FL. Job Title
Senior Project Engineer Responsibilities
Managing mid-to-large sized engineering projects by planning and tracking activities of cross-functional teams and contractors. Develop schedules and performance requirements using verification tools and techniques to manage project scope, schedule and cost, ensuring project goals are met on time and within budget. Analyze resources and priorities and perform risk management to minimize project risks. Develop and execute commissioning plans to ensure that process and utility systems and equipment are suitable for their intended use Develop and review process flow diagrams and P&IDs for new process and utility systems and modifications to existing systems Direct or assist in the design and execution of all capital projects assigned Support engineering development with load calculations of flow, heating/cooling capacity, pressures, etc. Prepare engineering evaluations, change control documentation, testing plans, CAPAs using strong technical writing skills Lead and assist in investigations of process systems and equipment to determine root cause and ensure corrective actions are initiated and implemented; use statistical tools to analyze data, predict trends, measure process capability, improve procedures, identify bottlenecks and equipment reliability Develop efficient preventive maintenance plans for key manufacturing and utilities equipment and provide troubleshooting expertise across operations and maintenance Serve as the technical liaison for OSHA, regulatory and other audits related to maintenance and facility aspects of the site Assist in writing regulatory documents for FDA submissions as required Create capital expenditure requests and purchase requisitions for approvals prior to procurement of process and utility systems and equipment Qualifications and Experience
Ability to follow cGMPs and procedures with great attention to detail Ability to read and understand blueprints Ability to evaluate and interpret regulations and recognize the need for changes to procedures Ability to work in a high-pressure, deadline-driven environment Provides feedback to operations management and staff regarding performance against SOPs; fosters collaborative relationships with operations management Advanced knowledge of standard office software (Microsoft Word, Excel, and Project) Excellent problem-solving and analytical skills; able to frame issues for non-technical colleagues Exceptional organizational and communication skills Good mechanical aptitude and knowledge of general maintenance Identifies ways to improve workflow and efficiencies within SOP constraints Excellent writing and verbal communication skills; able to translate technical concepts to both senior management and frontline staff Time management skills and ability to balance multiple assignments Experience
Minimum of 10 years of engineering experience in a cGMP Pharmaceutical/Biological manufacturing environment Benefits and Compliance
Comprehensive benefits package including 401K with employer match and immediate vesting; Medical, Vision, Life and Dental Insurance; Pet Insurance Company-paid STD and LTD; Company Paid Holidays; 3 Weeks’ Paid Time Off (within the first year) Tuition Assistance (after the first year) Easy access to Tri-Rail; Free shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm employment eligibility ADMA Biologics is an Equal Opportunity Employer
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