Master’s degree OR
Bachelor’s degree AND 2 years of Automation Engineering experience.
Shift: 12hrs shifts – 5pm a 5:30am
• Experience in Pharmaceutical, Medical Device or Biotechnology Industry.
• Experience bringing direct technical support to a Packaging Area.
• Support Operations in Non-Standard shifts that includes weekends and/or holidays as determined by business.
• Solid understanding in automation system (e.g. Vision System, Sensors, Data Acquisition, PLC, HMI, robotic, Industrial Printers, VFD, Conveyors)
• Solid Understanding in HMI, PLC, Computer Serialization, Packaging Equipment, Inspection System, Systech and/or Cognex Vision System, VFD, Conveyors, Many Others.
• Understanding in Pneumatics, Relays and Electrical Circuits.
• SCADA/ PLC Control System in regulated manufacturing environment, preferable pharmaceutical.
• Other Automated Control System to be supported includes Siemens and Rockwell HMI’s, Cognex Vision System, Sensor and Systech Serialization.
• Highly Technical and Customer Service Oriented (since we bring support to other operational areas).
Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.
The Sr. Associate Technical Engineering will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications and ensure that all of the maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards.
1. Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards, and FDA standards.
2. Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team.
3. Participate in the coordination of technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues, and process maintenance issues.
4. Assist the maintenance team during FDA and other regulatory agency inspections. Provide technical support to the maintenance team in response to the FDA and other regulatory agencies.
5. Assist the maintenance team when responding to high purity water systems and environmental monitoring alert/action notifications. Assist with the investigation on all alert/action notifications.
6. Assist with the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities, documentation, operations, and related areas to ensure a continued state of compliance.
7. Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
8. Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility, and clean room systems.
**Other functions that may be assigned
Master’s degree OR Bachelor’s degree and 2 years of Engineering experience.
Preferred skills in the following areas:
• Leadership and teambuilding
• Verbal communication
• Written Communication/Technical Writing
• Dealing with and managing change
• Comprehensive understanding of validation protocol requirements.
• Technical (Equipment Specific)
• Analytical Problem Solving
• Project Management & Planning
• Computer Literacy