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Job Requirements of Validation Engineer I:
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Employment Type:
Contractor
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Location:
Braintree, MA (Onsite)
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Validation Engineer I
Careers Integrated Resources Inc
Braintree, MA (Onsite)
Contractor
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.
SUPERVISION RECEIVED
Reports to the engineering supervisor or equivalent position
SUPERVISION EXERCISED
N/A
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
Generating, Reviewing, and Executing all Validation Documentation associated with Client's Validation Programs
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 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
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.
SUPERVISION RECEIVED
Reports to the engineering supervisor or equivalent position
SUPERVISION EXERCISED
N/A
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
Generating, Reviewing, and Executing all Validation Documentation associated with Client's Validation Programs
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 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
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