Engineering Document Control Specialist

Merck • Saint Louis, MO

10d

About The Position

In this role responsibilities include but are not limited to: Essential Job Functions: Coordinate the preparation, execution, scanning, and filing of validation protocols, maintenance work orders, and calibration certificates. Maintain engineering, maintenance, and validation quality systems in strict adherence to cGMP and regulatory requirements such as ICH Q7. Collaborate with Validation Engineers to ensure all technical documentation is accurately completed and archived in designated locations. Develop and maintain specialized databases to track various validation activities, maintenance work orders, and equipment calibration history. Oversee the administration of temperature and humidity monitoring instruments, including tracking locations and managing deployment. Manage the end-to-end calibration cycle, ensuring instruments are sent out on schedule, documentation is verified upon return, and equipment is properly returned to service. Assist in generating comprehensive reports for periodic system reviews and specific validation test cases. Provide essential documentation support for equipment commissioning and qualification, as well as gathering necessary data for internal, customer, and regulatory audits.

Requirements

• Associate’s Degree in Chemistry, Biology or other Life Science discipline.
• 1+ years’ experience supporting a GMP Manufacturing group.
• 1+ years’ experience in Trackwise, Mango, and SAP or other QMS and CMMS systems.

Nice To Haves

• Experience working with Validation or Quality teams in a GMP environment.
• Experience working with cross-functional teams.
• Strong oral and written communication skills.
• Experience with good documentation practices.
• Strong computer and document management skills.

Responsibilities

• Coordinate the preparation, execution, scanning, and filing of validation protocols, maintenance work orders, and calibration certificates.
• Maintain engineering, maintenance, and validation quality systems in strict adherence to cGMP and regulatory requirements such as ICH Q7.
• Collaborate with Validation Engineers to ensure all technical documentation is accurately completed and archived in designated locations.
• Develop and maintain specialized databases to track various validation activities, maintenance work orders, and equipment calibration history.
• Oversee the administration of temperature and humidity monitoring instruments, including tracking locations and managing deployment.
• Manage the end-to-end calibration cycle, ensuring instruments are sent out on schedule, documentation is verified upon return, and equipment is properly returned to service.
• Assist in generating comprehensive reports for periodic system reviews and specific validation test cases.
• Provide essential documentation support for equipment commissioning and qualification, as well as gathering necessary data for internal, customer, and regulatory audits.

Benefits

• health insurance
• paid time off (PTO)
• retirement contributions
• other perquisites

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree