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Validation Engineer || Location: Braintree, MA ||| Visa: Only USC GC at Braintree, Massachusetts, USA
Email: sandeep.s@winorbittech.com
From:

Sandeep,

WinOrbit

sandeep.s@winorbittech.com

Reply to:   sandeep.s@winorbittech.com

Title: Validation Engineer

Location: Braintree, MA(Onsite)

Duration: 12+ month

Interview: Skype/Phone

Visa: Only USC/GC Candidates

DESIRED MINIMUM QUALIFICATIONS

A minimum of bachelors 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 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

             Communicate effectively with cross-functional teams

Job 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 SOPs (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

             Generating, Reviewing, and Executing all Validation Documentation associated with their

             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

Keywords: green card Massachusetts
Validation Engineer || Location: Braintree, MA ||| Visa: Only USC GC
sandeep.s@winorbittech.com
sandeep.s@winorbittech.com
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09:58 PM 16-Jan-25


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Location: Braintree, Massachusetts