Automation Systems Engineer

~~The Automation Systems Engineer is responsible for leading the successful execution of the automation activities on our client site.  The Automation Engineer will have responsibility for managing regulatory aspects of the process automation and control systems used in the manufacture of sterile injectable products.  This position will provide engineering and technical support related to the operation, maintenance, installation, startup/commissioning, testing, and qualification of pack lines, serialization and visual inspection systems within a sterile injectable manufacturing facility.

• Responsible for the identification, development and implementation of automation projects which drive continuous improvement, productivity and sustainability of processes, controls, systems and equipment.
• Establishes priorities and develops action plans to drive improvement.
• Utilizes analytical, critical thinking, and structured root cause analysis techniques for problem solving.
• Maintains validated/qualified state throughout equipment lifecycle.
• Writing and preforming automation qualification protocols (IQ,OQ, PQ)
• Performs Functional Acceptance Tests (FAT)
• Aid in the automation skill development of Electronics/Metrology technicians
• Ability to provide Automation and controls training of new equipment

Requirements:
• Bachelor’s degree required, preferably in a technical area such as Mechatronics, Automation, Chemical, Mechanical, or Electrical Engineering.
• Minimum of 5 years in engineering roles supporting Automation controls
• Minimum 5 years hands-on engineering experience with projects, automation and manufacturing.
• Experience within a highly regulated environment required.
• Expert knowledge in areas of regulatory requirements as well as equipment system qualification and validation.
• Demonstrated ability to work with customer team members, technical experts, professional staff, and focus on customer satisfaction.
• Understanding of EHS, GMP, NEC, HIPPA, EPA and OSHA's regulations.
• Strong oral and written communication skills.
• Proficiency required with Process Control solutions including TIA, Step 7, GE iFix/iBatch, Rockwell’s Plant PAX, Wonderware, Emerson Delta V or equivalent SCADA process control system with S88 architecture.
• Experience with start-up and maintenance for interfaces to other third party applications and controls platforms such as but not limited to AS-I and Profibus IO systems.
• Network architecture, design and integration
• Expert in Active Directory and Domain administration including information security
• Expert with Rockwell Software and Controls