Engineering Compliance Specialist

The Engineering Compliance Specialist ensures the technical documentation and information for the Sterigenics Facilities is inventoried and available to reflect the accurate status of all current equipment and engineering processes.

The Engineering Compliance Specialists will develop, monitor, and maintain engineering technical documentation policies, processes, procedures and controls to ensure compliance with established standards, quality records and agency guidelines.

The Engineering Compliance Specialist will be the champion for all quality related Engineering documentation and track documentation changes as required by the Management of Control process including Change Requests, CAPAs, & SOPs.

A main objective for the Engineering Compliance Specialist is to ensure good documentation practices and timely action closure through the document full life cycle process.

DUTIES AND RESPONSIBILITIES:


* Provides oversight and guidance to sustain compliance with Regulatory, Corporate and Site processes for Engineering documentation, which includes all change controls, validation, commissioning, deviation, SOPs, capital project files, and drawings, and engineering turn over packages.


* Works with Document Control to ensure accurately maintained controlled filing storage systems for current and historical technical documentation & records.


* Develops and maintains appropriate change control policies and/or procedures to be applied to all Engineering documentation regardless of source, location, or media type.


* Controls lifecycle documents within scope of department such as CRs, SOPs, forms, technical reports, Validation Protocols and Reports, and drawings.


* Works with Engineering, Maintenance and Operations to maintain an accurate technical documentation library reflecting the facility equipment and systems is maintained in the Electronic Engineering Document Management System (EEDMS).


* Coordinate with the Engineering Document Manager to ensure consistent and efficient control, storage, copying and retrieval of all Engineering documentation.


* Develops, classifies, and reviews record retention schedules for Engineering Documentation.

Periodically reviews and updates retention schedules to reflect changes in legal and/or operational requirements.


* Maintains database tracking system for Engineering Documentation that manages change control and quality related requirements.


* Audits Engineering SOP's, document types, and training records to ensure compliance.


* Participates in all inspections and internal / external audits by facilitating document access as assigned.


* Coordinates and tracks all department EHS and Quality actions.


* Works with Maintenance and Reliability to verify vendor documentation is maintained in accordance with Good Documentation Practices


* Manages, monitors and expedites actions related to technical documentation change control


* Functions as lead deviati...