Automation CSV Support Engineer
- North America, United States
- Contract
- CAPEX Projects
Our client, a global pharmaceutical manufacturing organization are looking for a talented Automation CSV Support 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.
Essential Duties and Responsibilities for this role include, but are not limited to:
- Review and approve Kneat documents including: DeltaV software FATs, SATs, Automation Commissioning Test Protocols, software OQs, and Software Installation Verification protocols.
- Assist in resolving protocol execution issues using critical analysis and develop sound, reasonable solutions.
- Assist with the development of system requirements and specifications to ensure requirements are testable and meet 21 CFR Part 11.
- Support generation of Kneat documents.
- Review and approve Automation documentation including risk and impact assessments, computer systems validation plans, user requirements specifications, functional requirement specifications, trace-ability matrices, release reports, and all documents and deliverables within the scope of the Automation Master Validation Plan as needed.
- 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
- Coordinate with various project work-streams including Automation, Automation System vendor(s), CSV, CQV, Utilities, Process Engineering, and others as needed.
- Attend regularly scheduled project status meetings as needed.
- Complete Safety, Project Procedure, and Project Instruction training as required.
- Extensive direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulations
- Extensive direct Computer System Validation experience working with Emerson DeltaV DCS
- 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 required
- Excellent organizational, oral, and written communication skills and fluency in English with the ability to effectively communicate within cross-functional teams and to management
- Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
#LI-NR1
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
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
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
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