CQV Process Engineer

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­­This is Navya and I'm a recruiter at Intellectt, Inc. Please find the job description and contact me with an updated copy of your resume. You can send it to navyasri@intellectt.com or call me at 1(732) 982-2113

Job Role: CQV Process Engineer

Duration: 12 Month Contract

Location: Lebanon, Indiana

Job Description

As a Commissioning, Qualification, and Validation (CQV) Process Engineer, you will provide CQV services to clients in the Life Sciences industry. This role offers an excellent opportunity to work with a Global Engineering Firm and support clients in the manufacturing of life-changing products. You will be responsible for developing and executing CQV documentation for a variety of equipment, facilities, utilities, components, products, and systems.

Key Responsibilities

• Provide CQV process support to clients that manufacture GMP products.
• Develop CQV planning documents to manage CQV projects.
• Generate and execute CQV protocols using Good Documentation Practices (GDPs).
• Investigate and resolve protocol exceptions or discrepancies.
• Develop technical reports and CQV summary reports.
• Start-up equipment safely and effectively.
• Perform risk and impact assessments.
• Read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs).
• Develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, and other regulatory support documentation.
• Participate in integrated delivery (EPCMV) project teams.
• Apply engineering knowledge of manufacturing equipment, process equipment, HVAC utilities, instrumentation, controls, and automation.
• Lead tech transfer projects for clients.
  
  

Job Qualifications

• Bachelor’s degree in Chemical or Mechanical Engineering or equivalent experience.
• At least 2 years of CQV process engineering experience in the Life Sciences industry.
• Understanding of Good Manufacturing Practices (GMPs).
• Strong technical writing skills.
• Proficiency with Microsoft Office – Word, Excel, PowerPoint, Project.
• Change control management experience.
  
  

Skills

• Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations.
• Knowledge of industry guidance, including:
• 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.