The Specialist Tech 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. Ensure 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. Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team. Coordinate 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. Provide technical support for 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. Support the maintenance team when responding to high purity water systems and environmental monitoring alert/action notifications. Support the investigation on all alert/action notifications. Support 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. Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs. Evaluate sanitization and maintenance procedure s. Propose changes to the Department Manager. Propose modifications for process, utility and clean room systems to the Plant Engineering Group.
Education:
Doctorate degree OR Master's degree and 3 years of experience OR
Bachelor's degree and 5 years of experience OR Associate's degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Requirements:
Documentation changes, pest control program management support, deviations and Corrective and Preventive Actions (CAPAs), and Change Controls.
Job Type: Full-time
Schedule:
8 hour shift
Education:
Bachelor's (Preferred)
Experience:
Change Control: 5 years (Preferred)
Deviations: 5 years (Preferred)
CAPA: 5 years (Preferred)
Work Location: In person
