Responsibilities :

• Responsible for the maintainence and management of Site Automation Systems in particular Siemens Insight and InfoCenter for the Building Management System and Rockwell RS Logix for the Process Automation System.

• Strong PLC and HMI programming skills; must have proven hands on experience in PLC/HMI logic programming and troubleshooting Siemens, and Rockwell/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 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 maintainance 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, adhereing 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.

• Assist in writing regulatory documents for FDA submission as required. Must have impeccable writing skills.

• Initiate related purchase requisitions for outside services, parts and supplies as required.

• Continuously monitor the manufacturing operation to look for process optimization / debottlenecking opportunites and make techical 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.

• A Bachelor’s Degree Electronics/Electrical/Industrial Automation Engineering preferred.
• Minimum of five to seven years of solid process engineering/maintenance experience in a cGMP, Pharmaceutical/Biological manufacturing environment.
• Experience working with and knowledge of automation systems required.
• Other Essential Knowledge. Must have good attention to detail with good communication skills (both verbal and written) with a strong sense of commitment. Intermediate to high level expertise with software programs, which include Word, Excel, Power Point, Microsoft Project, and AutoCad needed for this position.
• Siemens Insight and InfoCenter and Rockwell RS Logix a plus