Engineering Investigator

Duration: 12 Months

Position Requirements:           

1. Compliance Investigations

2. All MS Office Products and Outlook including Teams

3. Excellent Technical Writing Skills, Communication - Written and Verbal.

Preferred Skills:

• Experience completing investigations is highly desirable.
• Experience with Veeva Vault is a plus.

Responsible for completing investigations for equipment/instrument failures along with human root causes when engineering personnel are involved. This position will report to the site's Engineering Systems Lead. The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports. The individual will be expected to develop collaborative relationships with the colleagues within Engineering, Maintenance and Utilities (EMU) and the appropriate Quality representatives in order to facilitate investigations using common investigation tools (5 whys, fishbone diagrams, etc.).

The incumbent will be expected to have experience in the area of quality and compliance and a working knowledge of the appropriate regulations.

Additional responsibilities and expectations include:

• Have a fundamental understanding of the investigation process as it applies to manufacturing issues
• Have general understanding of equipment, instruments and systems involved in the manufacture of bio pharmaceutical.
• Be able to use that knowledge to investigate deviations to identify root cause.
• Be able to interview subject matter experts.
• Work with the appropriate people develop a corrective action
• Ensure their investigations are conducted with a strict adherence to appropriate quality and compliance standards