Sr. Associate Technical Engineering (2122)
Juncos , PR 00777
InGente, Inc. is an affiliate of CPM, the largest Puerto Rican project management company, with over 26 years of experience. We provide human resources and flexible workforce solutions within several industries, including: Engineering & Construction, Information Technology, Science, Finance and Accounting, Professional and Administrative Services, Marketing and Communications, among others.
Important, please read carefully:
TheSr. Associate Technical Engineermust have experience in the following:
Experience in the configuration, support and testing of the following systems is required: SCADA/PLC control systems in regulated manufacturing environment, preferably pharmaceuticals. Other Automated Control Systems to be supported includes Siemens and Rockwell HMIs, Cognex Vision Systems, Sensors, and Systech Serialization (Track and Trace) systems. Automation technical knowledge for troubleshooting, investigations and training. Experience with automation system hardware and software support, including installation. Experience Supporting the validation of automation systems with the qualification and validation functions. Working knowledge of the process equipment, instrumentation, and/or computerized systems typically applied to packaging manufacturing processes.
_The Sr. Associate Technical Engineer_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
- Bachelors Degree in Science or Engineering, preferably Computer Science, Computer, or Electrical Engineering and 2 years of experience in automation equipment.
Preferred skills in the following areas:
Leadership and teambuilding
Written Communication/Technical Writing
Dealing with and managing change
Comprehensive understanding of validation protocol requirements.
Technical (Equipment Specific)
Analytical Problem Solving
Project Management & Planning
If you qualify for this position, we invite you to apply.Only qualified candidates will be considered.
We are an Equal Employment Opportunity Employer and take Affirmative Action to recruit Women, Protected Veterans and Individuals with Disabilities.