ICQ Consultants is looking to hire dedicated professionals in the NH, MA, RI, CT, NJ, PA, NC, and SC areas. ICQ is one of the largest and most sought after CQV suppliers in the Northeast and we have expanded with offices in the Southeast. We are seeking to hire mid to senior level Commissioning/Qualification/Validation, Technical Writing and Project Management staff.
The Commissioning/Qualification/Validation and Technical Writing positions have 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.
The Project Manager positions have responsibilities for all aspects of the management of small and large project’s (Tier 1, 2 and 3) demonstrating the ability to plan, coordinate, develop/manage/present budgets, schedules, and project metrics while ensuring quality and timeliness of project deliverables by the assigned team.
ICQ Consultants offers extremely competitive benefits and wages in our field of business. Many of the benefit premiums are 100% funded by ICQ:
- Tufts Health Insurance, Dental and Vision Plans
- Short Term / Long Term Disability
- Life Insurance
- Paid Time off for Holidays, Sick Time and Vacation
- 401 K with a 100% match to the first 4%
- Cloud Based and Class Room Style Internal ICQ Training
- A supportive management and leadership structure
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
All positions require a solid foundational understanding working in FDA-regulated industries within one of or more of the following areas of commissioning, qualification and/or Validation:
- Process Validation
- Sterilization Processes
- Packaging Line Processes
- Cleaning Processes
- Facilities, Utilities and Process Equipment
- Depyrogenation Processes
- Analytical Lab Processes
- Automation/Computer Systems (Delta V, 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