ICQ is Hiring!

The 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:

• Process 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.
• 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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