Validation/Equipment Engineer

Job Title: Equipment Engineer/Validation Engineer

Duration: 11 Month+ (possible extension)

Location: Boston, MA 02127

Pay rate: $55 - $65/hourly on W2

Description:

Equipment Engineer

Train at current Boston Facility

will be required to work on-site 5x a week

Role will relocate to Braintree location (Nov, Dec, Jan)

Please ensure this worker is OK with working at both locations - this is a requirement

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

2-4 years experience is OK

The team will be hiring ~2 engineers every 2 weeks to allow for proper training.

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