ICQ-1The Commissioning/Qualification and Validation Engineer position has responsibilities for all aspects of planning, coordination, development, execution and close out of commissioning, qualification and/or validation protocols/reports meeting quality and schedule expectations.

EXPERIENCE REQUIREMENTS

All positions require a solid understanding of the requirements for working in FDA-regulated industries within one of or more of the following areas of commissioning, qualification and/or Validation:

  • downloadProcess Validation
  • Clean Utilities
  • Sterilization and Decontamination Processes
  • Packaging Line Processes
  • Cleaning Processes
  • Facilities, Utilities and Process Equipment
  • Depyrogenation Processes
  • Analytical Lab Processes
  • Automation/Computer Systems (Delta V, Honeywell, Siemens, Snyder, Johnson Controls, PLCs, )
  • Project Management
  • Cycle Development
  • Shake down, Start-up and Turn Over Activities
  • Decommissioning Activities
  • Environmental Monitoring

GENERAL REQUIREMENTS

  • Working knowledge of FDA and ICH requirements:
    • 21CFR Parts 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packaging or Holding of Drugs General.
    • 21CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals.
    • 21CFR Part 11, Electronic Records and Electronic Signatures
    • ICH Q7, GMP Guide for Active Pharmaceutical Ingredients
  • Working knowledge of Quality by Design (QbD) principles and approach:
    • ICH-Q9, Quality Risk Management
    • ICH-Q10, Pharmaceutical Quality System
    • ASTM E2476, Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
    • ASTM E2500, Standard Guide for Specifications, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
  • Demonstrated ability to meet quality and schedule expectations related to the planning, coordination, development, execution and close out of commissioning, qualification and/or validation protocols/reports.
  • Demonstrated ability to customarily and regularly exercises discretionary powers and sound independent judgment.
  • Demonstrated ability to work independently or as an effective team member, leader, of project manager while completing all assign work.hire-expert
  • Demonstrated ability to clearly and effectively communicate with project team members, management, clients.
  • Demonstrated ability to take ownership in obtaining, interpreting and understanding client and vendor-supplied documentation in order to meet assignment deliverables and expectations
  • Participate in internal ICQ Consultants and industry required training to ensure continued accreditation.
  • Complete all others tasks within quality and schedule expectations as assigned.
  • Travel may be required.
  • Employee must always be compliant with the company’s Standard Operating Procedures (SOPs) and policies.
  • Strong attention to detail
  • Proficient in MS Word and MS Excel
  • Ability to handle many tasks with limited direction
  • Ability to deliver results is a must
  • Demonstrated interest in continued professional development
  • Demonstrated interest to provide a high level of customer support
  • Demonstrated interest to be a representative of the company
  • Desire to help others
  • Desire to be in industry leader
  • Belief that every problem has a solution


EDUCATION REQUIREMENTS

BS/BA degree in a Scientific/Engineering Discipline or 2 to 15 years’ related experience working in FDA-regulated industries within one of the following areas:

  • Manufacturing
  • Engineering
  • Process Development
  • Quality Assurance (QA)
  • Quality Control (QC
  • Commissioning, Qualification and/or Validation

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