What are the responsibilities and job description for the Validation Engineer I position at Integrated Resources, Inc ( IRI )?
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
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
- 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
- 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
