Equipment Validation Engineer II

Responsibilities:

Authoring and/or reviewing of SOP's (both new and existing).

Authoring and/or reviewing Equipment Requirements Specifications.

Document calibration and maintenance requirements, generate procedures.

Supporting Equipment Management Program.

Schedule and work with suppliers to perform service, installation, calibration, maintenance activities for facility, utilities, and equipment.

Troubleshoot manufacturing issues to identify root causes and implement corrective actions.

Initiate and/or execute Equipment Impact Assessments on failures.

Collaborate with cross-functional teams to drive continuous improvement efforts.

Communicates technical information within the team.

Primarily hands-on workers. Requirements:

Authoring and/or supporting efforts on any On the Job Training.

Execute Equipment Qualification Protocols.

Perform investigations and support CAPAs as needed.

Ensure proper documentation is completed to meet quality system requirements.

Ensure compliance with all applicable regulations and standards.

The employee may be required to perform other duties as assigned by management.

A minimum of bachelor's degree in Engineering or Technical field.

3+ years of prior experience with calibrations and maintenance activities preferred; regulated industry experience, medical device or pharmaceutical experience preferred.

Strong technical aptitude and problem-solving skills.

Ability to work independently and as part of a team.

Attention to detail and ability to maintain accurate records.

Machine shop experience preferred.

Communicate effectively with cross-functional teams.