Role: Validation Engineer

Location: Boston, MA

Duration : 11 Months - Onsite

**Preference given to Locals**

Roles & 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

• 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 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

**Only W2/1099 - No C2C**