Role: Validation Engineer II

Location: Boston, MA - 2127

Duration: 11 Months

SUMMARY DESCRIPTION

The Equipment Engineer is responsible for maintaining state-of-the-art GMP facilities and equipment.

The Engineer will coordinate cross-departmentally and with suppliers for equipment controls required to establish and document the Suitability for the Intended Use (including review of dFMEA, pFMEA, URS, vendor manuals, etc.)

Troubleshooting and testing of manufacturing instruments and equipment per the SOPs (Standard Operating Procedures).

The Engineer will assist with evaluation of equipment failures and determine the need for appropriate repairs and ensure all actions are documented appropriately.

ESSENTIAL DUTIES AND 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 cause 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 worker

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

ADDITIONAL RESPONSIBILITIES:

• 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

DESIRED MINIMUM QUALIFICATIONS

• A minimum of bachelor’s degree in and 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