CSV Automation Engineer
- East Coast
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
Our client, a global pharmaceutical manufacturing organization are looking for a talented CSV Automation Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.
CSV Automation Engineer Responsibilities:
- Assist in the generation and development of documents, processes, and procedures of the Computer Systems Validation (CSV) program.
- Develop Project Plans for the qualification of a Building Management System (BMS) and PLC based equipment for Drug Product (DP) and Finished Goods Manufacturing (FGM) areas.
- Develop Project Plans for the qualification of IT and Automation Systems such as PAS-X MES (Manufacturing Execution System), Aveva Wonderware SCADA, Siemens Simatic PLCs, and Allen-Bradley PLC controls.
- Generate and review Manufacturing and IT Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
- Ensure that the Computer System Validation on the project is conducted in a consistently high standard, within budget, and that objectives are met on time
- Bachelor’s degree in chemical engineering/ Computer Engineering/ Computer Science/ Biological Science (or equivalent)
- 5+ years’ direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulation
- Knowledge of Automation Control Systems, Manufacturing and IT Systems, and methodologies including ASTM2500, GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11
- Working knowledge of Kneat validation software is a plus.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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