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.
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
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
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:
- Process Development
- Quality Assurance (QA)
- Quality Control (QC
- Commissioning, Qualification and/or Validation