Senior Process Controls Engineer - ADMA Biologics
Boca Raton, FL
About the Job
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 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 Controls Engineer in Boca Raton, FL!
The Senior Process Controls Engineer is responsible for providing expert process control engineering, automation and maintenance support to the ADMA Manufacturing Facility. To develop and execute the maintenance/engineering tools/programs related to systems automation to ensure that the facility is kept in an operational state. Maintain all process equipment and utility systems that are cGMP compliant from a control engineering perspective. Direct and or assist capital engineering and process improvement projects. Serve as automation system, equipment and 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.
Qualifications- Responsible for the maintenance and management of the Siemens Insight/InfoCenter Building Management System.
- Strong PLC and HMI programming skills; must have proven hands-on experience in PLC/HMI logic programming and troubleshooting Siemens and Allen-Bradley products in systems in a pharmaceutical or biopharmaceutical manufacturing facility.
- Strong knowledge of process control and machine automation in biotech or pharmaceutical manufacturing facility.
- Working knowledge of engineering documentation required for cGMP process equipment, Software Lifecycle Documentation and GAMP V guidelines.
- Troubleshoot, modify and support all Site Automation Systems.
- Provide process engineering/process control 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.
- Create and maintenance of computer system life cycle documentation for all Automation Systems.
- Project management.
- Participate in commissioning and validation efforts for automation system installations and modifications.
- Oversee contractors’ adherence to standards outlined in specifications, adhering to protocols and completion dates.
- Responsible for generation and closure of Change Controls required for Site Automation Systems.
- Direct and or assist in the design and execution of all capital projects assigned.
- Asist in writing regulatory documents for FDA submission as required.
- Initiate related purchase requisitions for outside services, parts and supplies 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.
- Train and mentor less experienced staff as required.
Education Requirements:
Bachelor’s degree in Electronics/Electrical/Industrial Automation Engineering.
Experience Requirements:
Five to seven years solid process engineering/maintenance experience in a cGMP, Pharmaceutical/Biological manufacturing environment particularly with Siemens Insight/InfoCenter Building Management System
In addition to competitive compensation, we offer a comprehensive benefits package including:
- 401K plan 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)
- Easily accessible to Tri-Rail
- Free shuttle to the Boca Tri-Rail station
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 visit www.dhs.gov/E-Verify.
ADMA Biologics is an Equal Opportunity Employer.