Validation Engineer/Sr. (Contract) 25675
Validation Engineer/Sr. (Contract) 25675
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Job Description
Job Description
The Validation Engineer will report to the VCGT Validation leadership or an appropriate designee to execute Commissioning Qualification and Validation activities for Vertexs Cell and Gene Therapies Facility in one of their facilities located in South Boston Cambridge or Providence.
*** This role will require flexibility in hours some late afternoons or weekends ***
KEY RESPONSIBILITIES:
- Draft and implement Quality System documentation designed to establish good validation practices within the organization.
- Author URS IQ OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
- Support all stages of qualification of Analytical Instrument and Manufacturing equipment.
- Support all stages of qualification of automated manufacturing equipment for medical devices
- Conduct Analytical Instrumentation Qualifications in accordance with USP<1058> and Vertex SOPs.
- Conduct Automation Assessments to ensure compliance with 21 CFR Part 11.
- Coordinate with vendor personnel to schedule and execute of test plans if required.
- Coordinates with the internal stakeholders to safely and effectively schedule CQV activities whenever required.
- Effectively works with cross departmental stakeholders including but not limited to information services EH&S Global Security design teams and quality.
- Author documents related to or support process validation related activities that include but not limited to aseptic process simulations (APS) process performance qualification material qualifications etc.
- Develop cycles for sterilization processes and validate them if required.
- Completes Vertex assigned training and ensures that they are 100% compliant 100% of the time.
- Ensure that all Validation activities align with the current Vertex SOPs global standards and cGMP guidelines.
- Supports right-the-first time culture for all documents distributed across the organization. Ensure the VCGT Validation team reputation and partnership is flourished with the cross-functional teams.
IDEAL CANDIDATES:
- Demonstrated ability to safely execute Validation activities in a dynamic fast paced environment.
- Experience developing and executing Validation protocols in a GMP Manufacturing and Analytical Laboratory areas.
- Receptive to change Adapts (quickly) to changing circumstances.
- A B.S. in Engineering or related discipline with 3-8 years of Validation experience or equivalent professional experience.
- Understanding and application of technical principles theories and concepts in the field GMP ISO GAMP ANSI.
Pay Range
$45-65/hr - depening on experience - Jr./Sr. Level
Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by law. In addition this role will be eligible for overtime pay in accordance with federal and state requirements
By applying for this position you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials which may include your CV/Resume email address or phone number with Vertex. For more information on how Vertex handles your personal data related to your job application please see Vertexs Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings profiles articles news and other employment-related information as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
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If you do not agree with the Atrium Terms and Conditions you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email.
No C2C or Third-Party Vendors
Required Experience:
Senior IC
Employment Type
Full-Time
