CSV Engineer

CSV Engineer

Title: 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

• 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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