Validation Engineer I - Aditi Consulting
Boston, MA 02127
About the Job
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
ADDITIONAL RESPONSIBILITIES:
DESIRED MINIMUM QUALIFICATIONS
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
#AditiConsulting
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 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
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
#AditiConsulting
Source : Aditi Consulting
