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Computer Systems Validation Engineer

Portsmouth, NH 03801

Employment Type: Contract Industry: Technology Job Number: 59918 Office Location: Portsmouth

Job Description

We have partnered with a client who is looking for a CSV Engineer to work on a temporary contract for 1 year +.  
Seeking no less than 5 years of CVS/Automation experience working with systems such as PCS (DeltaV) / BAS (Rockwell) / MES (Syncade) and Pi Historian / SCADA / PLC
Must have Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements.

• 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
• Manage, document, and assess the software changes throughout the SDLC following Lonza procedures.
• 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
• This role is 100% onsite in Portsmouth, NH.  NO RELOCATION; must be local.
Pay range starts at $50 per hour and up depending on experience.
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