Sr. Associate Manufacturing Systems Job at ISPV, INC.
Master’s degree or Bachelor’s degree and 2 years of Engineering experience or Associate’s degree and 6 years of Engineering experience or High school diploma / GED and 8 years of Engineering experience.
-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.
- Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team.
- 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.
- 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.
- 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.
- 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.
Job Type: Contract
Salary: $31.00 - $39.00 per hour
Schedule:
- 12 hour shift
Ability to commute/relocate:
- Juncos, PR 00777: Reliably commute or planning to relocate before starting work (Required)
Experience:
- Manufacturing: 1 year (Preferred)
Shift availability:
- Overnight Shift (Preferred)
- Night Shift (Preferred)
Work Location: One location
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