Position: CSV Engineer
Company: Intetics
Experience required: 3y
Category: Other
English level: upper
Published: 2023-04-01T00:00:00+03:00

Description
Intetics, a leading global technology company providing custom software application development, distributed professional teams, software product quality assessment, and “all-things-digital” solutions, is looking for a CSV Engineer to enrich its team with a skilled professional.

We are looking for a passionate, ambitious software engineer who is able to take responsibility for the front-end of our product and is able to select the right technologies and tools to build the solution within our set of core technologies. If you are ready to learn Go and are able to turn those into a working solution for the client we invite you to join our team.

Requirements
• Degree in a software or engineering related discipline
• +4 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry
• Strong experience in one or all the following systems: DeltaV, PCS7 (or other PLC/SCADA), OSI PI.
• Preferably MSD SDLC experience i.e. (MDS GAMP 5 approach)
• Sound understanding of 21CFR part 11 guidelines and GMP processes
• Hands on experience in creating/reviewing compliance lifecycle deliverables
• Experience with process plant commissioning.
• Experience in automation design & commissioning



Responsibilities:

• Follow Computer Systems Validation (CSV) Master Plan to author, review and approve CSV deliverables for systems

• Generate and review CSV deliverables in compliance with 21CFR Part 11 and GxP FDA Compliance Regulations
• Assist in planning and documenting validation project plan, review engineering reports and risk assessment to identify gaps and recommend necessary development
• Follow Computer Systems Validation (CSV) Master Plan to author, review and approve CSV deliverables for systems as per GxP FDA Assessment
• Author of URS, FDS, FAT and SAT documents and project deliverables documentation.