Operations Engineer

Summary of Position

The Operations Engineer will work in a dynamic organization in the Operations team for North America. This role has the responsibility for supporting the on-time execution and delivery of sterile drug products. This role will report to the Director of Operations.

The Operations Engineer is the primary Operations contact to ensure reliability and quality compliance for manufactured products. This drives reliability improvements and takes a lead role investigating or reviewing deviations / out of specifications with root cause analysis tools to ensure appropriate corrective actions are identified to reduce / prevent recurrence.

Work Schedule : 8am - 4 : 30pm Monday - Friday

Essential Functions

• Maintain and manage to closure a list of reliability related improvement efforts for operations and engineering.
• Manages projects or initiatives specifically related to reliability improvements.
• Author and review Change Control / Quality Documents involving product or process changes.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC / S, ISO, USP, NRC, cGMP, etc.).
• Review validations (equipment, cleaning and / or process) for assigned area.
• Prepares and participates in regulatory agency (i.e. FDA, HC, TGA, etc.) audits as well as internal audits.
• QA contact for risk management activities, including FMEA’s (Failure Modes and Effects Analysis).
• Investigate customer complaints, deviations / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented in the sites EQMS (Electronic Quality Management System).
• Assemble, analyze and report batch data to ensure regulatory compliance, identify trends and to identify areas of improvement.
• Develop, review and / or revise SOP (Standard Operating Procedures), BR’s (Batch Records), OJT / OJQs, FMEA’s with appropriate change management.
• Ability to adapt quickly in a fast-paced dynamic environment.
• Ability to quickly investigate and close deviation records ahead of product release.
• Ability to communicate with and positively influence broad and diverse cross-functional teams within and outside the organization.

Requirements

Working Conditions :