Validation Engineer Contract 24549
Validation Engineer Contract 24549
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Job Description
Job Description
The Engineer is actively involved in Commissioning Qualification Validation and Requalification activities for Vertex Cell and Gene Therapy facilities. The individual is responsible for executing qualification protocols at the Vertex facilities and collaborate with Global Engineering Facilities Operations GIS QA and PMO throughout the life cycle of the project.
This position reports directly to the Manager of Validation.
Key Responsibilities:
The responsibilities of this position may include but are not limited to the following:
- Develops and executes qualification and validation test plans and protocols for systems such as singleuse bioreactors QC instruments refrigerators incubators and autoclaves.
- Develops and executes Environmental Performance Qualifications analyses results and generates reports.
- Develops and executes IQ OQ and PQ qualification protocols for utility systems.
- Develops and executes IQ OQ and PQ qualification protocols for biosafety cabinets.
- Ensures that all validation documents align with the current Vertex SOPs global standards and cGMP guidelines.
- Coordinates with personnel onsite and other vendors to schedule and execute test plans.
- If required coordinates with the construction team and Vertex operations teams to schedule of validation activities safely and effectively.
- Effectively works with cross functional departmental stakeholders PMO GIS EH&S Global Security design teams EHS and QA.
- Completes Vertex assigned training and ensures that they are 100 compliant 100 of the time.
- Supports rightthefirst time culture for all documents distributed across the organization.
- Ensures the Global Engineering reputation and partnership is flourished with the crossfunctional teams.
Minimum qualifications:
- Receptive to change Adapts (quickly to changing circumstances.
- Minimum bachelors degree in an Engineering (Chemical Biomedical Industrial Biotechnology) or related discipline with 24 years 4 for Sr. of CQV experience or equivalent professional experience.
- Selfmotivated and must be able to work independently with minimal supervision and direction.
- Experience in developing and executing protocols in GMP industry.
- Experience using Kaye Validator and Data loggers.
- Understanding and application of technical principles theories and concepts in the field GMP ISO GAMP ANSI.
- Ability to learn and demonstrate technical problem solving and troubleshooting skills.
Pay Range
$40$55/hr based on experience
Requisition Disclaimer
This job posting is for a temporary role with a thirdparty 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 thirdparty 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 jobrelated 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 employmentrelated 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 ThirdParty Vendors
Employment Type
Full-Time
