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Apply online for the
Computer Systems Validation Engineer
position and advance your career in the
Pharmaceutical industry today.
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Computer Systems Validation Engineer : E-Technologies Group
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| Description |
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E-Technologies Group is seeking to fill a direct hire position for a Computer Systems Validation Engineer. Essential job duties include the development and execution of validation documentation including VP, Trace Matrices, IQ, OQ, and Summary Reports to maintain processes, systems, and equipment in a validated state per URS and SDS information. This position also requires participation in training with internal and external departments on the development and execution of validation protocols. Ideal candidates will have some combination of the following skill sets. |
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| Requirements |
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All candidates should meet the following minimum requirements:
• BS or MS in Engineering, computer sciences or physical/life sciences or equivalent experience
• Computer System Validation project experience
• Must have minimum 5 years experience in participating in the validation of and/or validating automated/PLC controlled equipment and processes, or, a combination of at least 2 years experience in programming automated/PLC controlled equipment and processes, and 3 or more years experience in participating in the validation of and/or validating automated/PLC controlled equipment and processes
• FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the Pharmaceutical Industry.
• Ability to read/interpret electrical schematics, P&ID’s, AF&ID’s, and related design material
• Ability to work within Project Scope, Schedules and Budgets under the direction of a project manager
• Knowledge of cGxP requirements
• Self starter with excellent written and oral communication skills
• Ability to work in a dynamic, fast paced environment while exercising excellent decision making and time management skills
The following are desirable attributes:
• GAMP 5/SDLC expertise
• Working knowledge of 21 CFR Parts 210 and 211, and 21 CFR Part 11
• Integrated C&Q methodology experience
• PLC/HMI/Batch programming experience
• SOP development experience
• Experience with validating: CIP & SIP Processes, RSBatch recipes, Filling Lines and/or Packaging Lines
• Familiarity with Trace Matrix and Summary Report development. |
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