CSV Engineer - SCADA

US$60.00 - US$65 per hour
  1. Permanent
  2. Validation
  3. United States
Kalamazoo, Michigan
Posting date: 16 May 2019
EN.KM.23308_1557987131

An international civil engineering firm is currently recruiting for a Computer System Validation (CSV) Engineer - SCADA to join their office in Michigan. The company provides a full spectrum of services including scientific, technical, professional and construction- and program-management for business, industrial, commercial, government and infrastructure sectors. The position provides an excellent opportunity to work for a Global Engineering Firm and support clients that manufacture life changing products.

The CSV Engineer will provide CSV services to clients in the Life Sciences Industry and will be responsible for the development and execution of CSV documentation on a SCADA control system for an aseptic fill line and its associate equipment.

Job Responsibilities:

  • Providing CSV/CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices.
  • Developing CSV/CQV planning documents to manage CQV projects.
  • Generating and executing CSV protocols (IQ/OQ/PQ) using Good Documentation Practices (GDPs).
  • Investigating and resolving protocol exceptions or discrepancies.
  • Developing technical reports and CSV summary reports.
  • Overseeing startup equipment and systems in a safe and effective manner
  • Developing GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS and summary reports.
  • Performing risk assessments and impact assessments.
  • Applying engineering knowledge of, aseptic processing equipment, and its associated automation to support project needs.

Skills and Requirements:

  • A BA or BS degree, preferably in the sciences or business-related disciplines.
  • Experience with CSV documentation.
  • Demonstrable project management skills.
  • 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.

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