Equipment Engineer

Job Title

Responsibilities:

• Authoring and reviewing of SOP's (both new and existing).
• Authoring and 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 cause and implement corrective actions.
• Initiate and 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.
• Authoring and 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.

Requirements:

• 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.