CSV Engineer - Data Integrity

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United States
Philadelphia, Pennsylvania
Posting date: 30 Jul 2019

ProClinical is advertising a vacancy for an CSV Engineer- Data Integrity position with a global biopharmaceutical company. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD) and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.

Job Responsibilities:

  • Authoring/updating of User Requirements, Functional Specification, and Design Specifications.
  • Review and Approval of Design Qualification and Traceability Matrix.
  • Review and Approval and Execution of IOQ/PQ protocol addendums.
  • Review and Approval Validation Reports.
  • Knowledge of Rockwell Software and GMP Equipment (e.g. autoclaves, packaging equipment, form/fill equipment).
  • There is some potential for execution and authoring of documents.

Skills and Requirements:

  • Demonstrable experience or training in a relevant or similar field.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at +44 207 440 0679 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.