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CSV Engineer

Company: Trinity Consultants - Advent Engineering Life Scie
Location: Dayton
Posted on: January 16, 2022

Job Description:

CSV EngineerADVENT Engineering, a pharmaceutical engineering firm, is currently seeking Commissioning/Validation Specialists/Engineers to work a variety of regulated industry projects. Qualified candidates will participate in start-up, commissioning, and validation activities for our clients within FDA regulated industries including pharmaceutical, biotechnology, medical device, and medical diagnostic.
The successful candidate will generate and execute Validation Life Cycle documents for computerized system within a Pharmaceutical/Biotech environment.
Responsibilities will include participating in project teams to accomplish validation projects, and representing validation on interdisciplinary facility teams. Knowledge of GAMP and of 21 CFR Part 210 & 211 and 21 CFR Part 11 requirements.

The Validation Specialist is an intermediate to senior level position requiring experience in various areas of computer system validation including plant floor manufacturing systems, laboratory systems and enterprise systems, as well as Change Control processing for those systems.
Validation of all computerized systems and instrument software including:
-- Master Validation Plan development-- Functional requirements, risk assessment and execution of validation protocols-- Data integrity and compliance to 21CFR Part 11 and GxP standards-- Prepare draft and final SOPs and compliance documents-- CCR and validation management-- Validation of spreadsheets and other laboratory working documents-- Review and remediate non-compliance and audit issues-- Liaise with and key stake holders in automation, manufacturing and QC laboratories-- Knowledge of the following systems is preferred:-- Building Automation Systems (Honeywell, Siemens, Andover)-- Plant floor Automation, PLC/SCADA (Rockwell, Wonderware, Intellution, Siemens)-- DCS Systems (Delta V, Honeywell, ABB)-- MES Systems (Werum, Honeywell, Rockwell)-- Laboratory systems-- Enterprise Systems (ERP, MES.)-- Execute IC/OC commissioning protocols for fermenters and the CIP skid
Knowledge in drafting and executing the following Life Cycle Documentation is mandatory:-- URS (User Requirement Specification)-- FRS (Functional Requirement Specification)-- FRA (Functional Risk Assessments)-- Risk Assessments (Compliance, 21 CFR Part 11)-- DDS (Detailed Design specification)-- FAT (Factory Acceptance Testing)-- SAT (Site Acceptance Testing)-- CSV (Computer System Validation)-- IQ (Installation Qualification)-- OQ (Operational Qualification)-- PQ (Performance Qualification)
Requirements:-- Bachelor's or Master's degree in Science, IT/OT, Engineering, or equivalent experience-- A thorough understanding of the GMP regulatory environment, validation, and associated subjects-- An ability to work independently-- Excellent verbal and written communication skills-- Proficiency in Windows and Microsoft Office applications

The successful candidate will generate and execute Validation Life Cycle documents for computerized system within a Pharmaceutical/Biotech environment.
Responsibilities will include participating in project teams to accomplish validation projects, and representing validation on interdisciplinary facility teams. Knowledge of GAMP and of 21 CFR Part 210 & 211 and 21 CFR Part 11 requirements

Keywords: Trinity Consultants - Advent Engineering Life Scie, Trenton , CSV Engineer, Engineering , Dayton, New Jersey

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