Validation and Compliance Engineer (CSV) - 3043
Boston, MA 02139
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Validation and Compliance Engineer (CSV)
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: 12+ month contract
- Pay rate: $70-$79.41/hr
- Job Location: Boston, MA
- Job#: bh14098
Validation and Compliance Engineer (CSV)
In order to set expectations and to the extent permitted by applicable law, please note that if an applicant is hired for this position, the applicant will be required to prove that the applicant has been fully vaccinated against COVID-19 by the date of hire, subject to any qualified religious or medical exemptions. Please note that the employer reserves its rights to mandate additional vaccine requirements at any time.
- The CSV will document and validate the deployment of Windows 10 upgrades and document changes respectively.
- Candidate will write, edit, route, and approve appropriate documentation associated with each system upgrade and good documentation skills are a must. Candidate will need to be able to execute test protocols as needed for each upgrade.
- Candidate will need to be able to work on multiple projects at the same time and manage priorities. Working independently is a must.
- The Analyst will provide project management updates to both customer and PE management and must be willing to travel to customer site.
- Design, Author, and Execute Computerized System Validation (CSV) – according to GAMP 5 guidance – especially on Analytical Laboratory Test Equipment and other Lab Information Systems
- Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
- Translate technical information and requirements into qualification/validation test design
- Serve as lead on validation projects
- Serve as primary point of contact with customer
- Serve as mentor to team members as needed
- Contribute to the overall growth of the company’s compliance business
- Bachelor’s degree (in science preferred)
- Experience leading a project and mentoring team members a plus
- Experience working in a regulated laboratory environment preferred
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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