Job Description:
CQV
Engineer -
Charles City IA.
(Pharmaceutical/Biotech)-Competitive Salary, Work/Life Balance!
On-Site
Previous Pharmaceutical/Biotech/Medical Device industry experience is mandatory for these roles.
Are you looking to be a part of a close-knit work community? Do you have experience in the Life Science industry? Will you represent Compli, LLC as an experienced CSV Engineer for our pharmaceutical manufacturing, biotech, and medical device client projects? Do you enjoy traveling the country and making a difference? If so, this could be the right opportunity for you!
The Engineer will work closely with the client to provide innovative solutions to our clients. We are experiencing growth as a firm and are seeking a qualified Engineer with expertise in CSV, and Automation. The ideal candidate will be a self-starter who takes pride in their work and actively pursues opportunities to learn and assist others when needed.
Job Summary
Needing CQV Engineers across several different validation disciplines: utility validation (mainly critical utilities but also some non-critical), equipment validation (solid dosage, liquid fill manufacturing equipment, tanks, etc.), experience with aseptic filling, and equipment automation computer validation (PLCs, Honeywell, Allen-Bradley, etc.).
Job Responsibilities
- Computer Systems Validation Engineer (Automation)
- Minimum 5 years' experience with Computer System Validation focused on equipment automation, BAS and DCS systems.
- Must have experience related to performing Risk Assessments on Alarms.
- Experience needed includes document preparation, protocol execution, risk assessments and CSV related document (Trace Matrices, SLIA, etc.) preparation.
- Need strong technical writing and communication skills.
- Develop documents (protocols, summary reports, etc.), execute protocols and test scripts, coordinate activity with clients and manage schedule and deliverables for the scope of work.
- Promote the need for clean, reliable and accurate data, by acting as a tangible function of the firm's data governance framework - ensuring data is cared for through its complete lifecycle, as an enterprise asset.
Compli, LLC was founded in 2001 to provide commissioning, validation, and regulatory support services, CQV, asset management, reliability engineering, and staff augmentation services to the life sciences industry. We serve pharmaceutical companies across the U.S. Regarding regulations and compliance, it has never been more important to understand the documentation and quality assurance activities as they relate to vendors, engineering, construction, and contractors, which is why clients trust the Compli team.
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