Computer System Validation (CSV) Engineer
- North America, United States
- Contract
- CAPEX Projects
This vacancy has now expired
This is a fantastic opportunity for a Computer System Validation (CSV) Engineer to join our major, global pharmaceutical client on their latest new-build project based in Ohio, this is a large-scale greenfield capital project and investing more than $1bn.
Job Responsibilities:
- Develop Project Plans for the qualification of the Drug Substance Manufacturing (DSM), Drug Product (DP), Finished Goods Manufacturing (FGM) Manufacturing, and IT Computerized Systems
- Assist in the generation and development of documents, processes, and procedures of the Computer Systems Validation (CSV) program
- 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 suiting the company's vision and objectives
- Collaborate and align with other Diosynth Biotechnologies sites
- Coordinate with Computer System vendors as needed
- Opportunities to make periodic International and Domestic travel Requirements
- Bachelor’s degree in Chemical Engineering, Computer Engineering, Computer Science, Biological Science, or technical equivalent
- Extensive direct Computer System Validation experience in a cGMP Pharmaceutical facility working with FDA regulations
- Knowledge of Automation Control Systems, Manufacturing & 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
- Excellent oral and written communications skills and fluency in English
- Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals
- Knowledge with Drug Substance Manufacturing (DSM), Drug Product (DP), and/or Finished Goods Manufacturing (FGM) would be beneficial
#LI-AN1
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing'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 QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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 QCS Staffing. 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
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