Validation Engineer I - Integrated Resources, Inc
Braintree, MA 02184
About the Job
ONSITE 5x a week - no exceptions!
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 Integra 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
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 Integra 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
Source : Integrated Resources, Inc