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Job Requirements of Validation Engineer II:
-
Employment Type:
Contractor
-
Location:
Boston, MA (Onsite)
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Validation Engineer II
Careers Integrated Resources Inc
Boston, MA (Onsite)
Contractor
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)
There is free parking garage and a shuttle at the current boston site, but there will be parking lot at new facility. All free
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
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
Train at current Boston Facility
WILL BE REQUIRED TO WORK ON-SITE 5x A WEEK
Role will relocate to Braintree location (Nov, Dec, Jan)
There is free parking garage and a shuttle at the current boston site, but there will be parking lot at new facility. All free
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
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
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