Validation Engineer - Kelly Services
Braintree, MA 02127
About the Job
Kelly Services is currently seeking for a Validation Engineer for one of our top clients in Braintree, MA.
JOB TITLE: Validation Engineer
INDUSTRY: Medical Device
LOCATION: Braintree, MA
DURATION: 12 Months (Temporary / Contract)
PAY RATE: $60 - $65 per hour W2
JOB DESCRIPTION:
Validation Engineer
In person role
ONSITE 5x a week
Validation Engineer
Braintree, MA location
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 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
Why Kelly?
Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.
As a Kelly Services employee, you will have access to numerous perks, including:
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
JOB TITLE: Validation Engineer
INDUSTRY: Medical Device
LOCATION: Braintree, MA
DURATION: 12 Months (Temporary / Contract)
PAY RATE: $60 - $65 per hour W2
JOB DESCRIPTION:
Validation Engineer
In person role
ONSITE 5x a week
Validation Engineer
Braintree, MA location
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 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
Why Kelly?
Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.
As a Kelly Services employee, you will have access to numerous perks, including:
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly Learning Center
- Weekly pay and service bonus plans
- Group-rate insurance options available immediately upon hire*
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Source : Kelly Services