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CSV Engineer - Portsmouth, United States - The Staffing Resource Group Inc
Description
CSV EngineerTitle:
CSV Engineer
Location:
Portsmouth, NH
Industry:
Pharmaceutical
Hours:
M-F: 8am-5pm (onsite)
Compensation:
W2, up to $68/hr. paid weekly (Benefits Available)
Employment Type:
Contract - possible extension
Environment:
A global leader and trusted supplier in the pharma, biotech and specialty ingredients markets.
Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities.
The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.
Duties may include any of the following:
Manage, document, and assess the software changes throughout the SDLC following procedures.
Author, Review, Approve and Execute CSV life cycle documentation
Knowledgeable of S88 Batch Standard is preferable
Recipe management DeltaV software development and testing is preferable
MES Recipe authoring and testing is preferable
Implementation and validation of QC system is preferable
Experience with Kneat is preferable
Strong verbal and written communication skills
Education and Experience:
CSV /Automation experience of 5+ years
Hands on experience in Implementation & Validation of various computerized systems like PCS (DeltaV) / BAS (Rockwell) / MES (Syncade) and Pi Historian / SCADA / PLC
Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements.
Experienced at working independently as well as in a team-oriented, collaborative environment is essential
Experience working with and programming/commissioning/validating Delta V software platforms
Extensive understanding of 21 CFR Part 11/Annex 11, GAMP 5, and other regulatory guidance associated with computer/automation based systems
Experience within pharmaceutical or related regulated industry is highly preferred
Must be authorized to work in the United States
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services.
SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements.
We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.EOE/ADA
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