Role: Validation Engineer I

Location: Boston, MA - 2127

Duration: 6 Months

SUMMARY DESCRIPTION

The Validation Engineer is responsible for Qualifying state-of-the-art GMP equipment.

The Engineer will coordinate cross-departmentally and with suppliers for equipment controls and qualification 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 re-qualification and ensure all actions are documented appropriately.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Authorizing and reviewing equipment installation qualifications

• Authoring and/or reviewing of SOP’s (both new and existing)

• Authoring and/or reviewing Equipment Documentation

• Supporting Equipment Management Program

• Schedule and work with suppliers to establish equipment controls required to assure the equipment performance

• Troubleshoot manufacturing issues to identify root cause and implement corrective actions

ADDITIONAL RESPONSIBILITIES:

• Execute Equipment Qualification Protocols

• Perform investigations and support CAPAs as needed

• Ensure proper documentation is completed to meet quality system requirements

DESIRED MINIMUM QUALIFICATIONS

• A minimum of bachelor’s degree in and Engineering or Technical field

• 3+ years of prior experience with Equipment Qualification/Validation activities preferred;

• regulated industry experience, medical device or pharmaceutical experience preferre