Senior CQV Engineer - Cincinnati, United States - Creative Solutions Services, LLC

Description

Responsibilities:
Bachelor's degree in mechanical, Chemical, or Electrical Engineering or equivalent years of experience in lieu of degree
At least 8 years of CQV experience in the Life Sciences industry
Understanding of Good Manufacturing Practices (GMPs)
Strong technical writing skills
Commissioning and Qualification experience of the following equipment and systems
Serialized Packaging equipment Cartoner, Case Packer

SCADA
Warehouse Execution System
AHUs
PQ and PPQ development, execution
Proficient with Microsoft Office – Word, Excel, PowerPoint, Project
Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
Knowledge of industry guidance
ISPE Baseline Guide 5 Commissioning and Qualification
ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ISPE Guideline Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
ISPE Good Practice Guide Applied Risk Management for Commissioning and Qualification, 2011
Six Sigma Certification

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