Senior systems engineer Jobs in Coral Springs, FL

Job Details

Job Location

ADMA Biologics FL - Boca Raton, FL

Education Level

4 Year Degree

Description

ADMA 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 thebiopharmaceutical industry that is committed toexcellence andintegrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Senior Project Engineer in Boca Raton, FL!

The general purpose of the Senior Project Engineer is to provide engineering, project management, manufacturing and maintenance support to the GMP manufacturing site. Ability to troubleshoot, problem solve and implement engineering solutions for existing manufacturing processes and equipment. Direct, evaluate and assist capital engineering and process improvement projects. Design, procure and commission new process and utility equipment and upgrades to existing systems.

Qualifications

Essentials of the job :

• Managing mid-to-large sized 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. Analyze resources and priorities to be applied to assigned projects and perform risk management activities 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 piping and instrumentation drawings (P&IDs) for new process and utility systems and modifications to existing systems
• Direct and 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.
• Utilize strong technical writing skills to prepare engineering evaluations, change control documentation, testing plans, corrective and preventive actions (CAPAs)
• Lead and assist in investigations of process systems and equipment to determine and document root cause and ensure the appropriate corrective actions are initiated and implemented. 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.
• Help develop efficient PM plans for all key pieces of manufacturing and utilities equipment and provide troubleshooting expertise in all areas of plan operations and maintenance.
• Serve as the technical liaison for all OSHA, regulatory and other audits that relate to the maintenance / facility aspects of the manufacturing facility
• 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
• Education Requirement :
• Bachelor's degree in Mechanical, Biochemical, or Chemical Engineering.
• Experience Requirement :
• Minimum of 10 years of engineering experience in a cGMP Pharmaceutical / Biological manufacturing environment.

Other Essential Knowledge :

Able to coordinate and complete complex projects; excellent written and oral communication and presentation skills; computer literate in word processing and data entry; extensive experience with MS Project or Smartsheets, AutoCAD and maintenance planning / scheduling related software; excellent problem-solving skills, detail oriented, and excellent mechanical aptitude, mathematical and statistical analysis skills.

Contacts :

Internal : Daily contact immediate supervisor, manufacturing managers / personnel and other support groups, and as required other ADMA employees to research, resolve, or provide information.

External : Frequent contact with vendors and contractors.

Working Conditions :

Physical Demands : Sit at a desk using a computer. Some heavy lifting required, field verification of equipment and systems in cleanroom and utility spaces, escorting contractors.

Stressors : Production schedule changes and equipment breakdowns etc., frequent changes in priorities and managing multiple projects with aggressive timelines.

In addition to competitive compensation, we offer a comprehensivebenefits package including :

ADMA 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 visitwww.dhs.gov / E-Verify.

ADMA Biologics is an Equal Opportunity Employer.