Role : Validation Engineer II

Location : Boston, MA - 2127

Duration: 11 Months

Job Description:

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

• Prior experience with calibrations and maintenance activities preferred; regulated industry experience, medical device or pharmaceutical experience preferred

• Attention to detail and ability to maintain accurate records

• Machine shop experience preferred

Interview:

• will consist of 1 phone screen and 1 on-site interview