ICQ Consultants is looking to hire dedicated professionals in the MA, NC, NJ and PA 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 as well. We are seeking to hire mid to senior level Validation staff.
Integrated Commissioning & Qualification, supplies services in the life science industry. In addition to offering commissioning and qualification services, we also offer QA, QC, Engineering, PV, PM and technical writing staff.
We focus on the commissioning effort in alignment with qualification, which can leverage many aspects of those efforts with complying to procedures and quality systems.
Our company provides some of the most competitive benefits and wages in our segment of service provider which include the following:
- Tufts Health Insurance, Dental and Vision Plans – Paid 100% by ICQ
- Short Term / Long Term Disability – Paid 100% by ICQ
- Life Insurance – Paid 100% by ICQ
- Paid Time off for Holidays, Sick Time and Vacation
- 401 K with a 100% match to the first 4%
GENERAL RESPONSIBILITIES AND REPORTING/EDUCATION/EXPERIENCE
These positions report to the assigned manager and have responsibilities for development and execution of commissioning and qualification protocols, including test functions, and sampling. Employee must always be compliant with the company’s Standard Operating Procedures and policies. Adherence to timelines and deliverables are a must. Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving one or more of the following:
- 5 to 7 years’ experience in Cleaning Validation and/or Sterilization
- 5 to 7 years’ experience in Environmental Monitoring
- 5 to 7 years’ experience in Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment
- Knowledge of FDA requirements, including cGMP’s, Quality System Remediation and Quality by Design, ICH-Q9, ICH-Q10, ASTM E-2500 principles.
- BS/BA degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
- Develop and execute commissioning/validation plans, test plans, validation protocols/reports and procedures.
- Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
- Work as a leader, part of commissioning/validation team, or independently to develop protocols and procedures, execute same including test functions, sampling and calibration.
- Responsible for developing new business opportunities at assigned client sites.
- Communication with management, clients, and project team members.
- Participate in training to ensure continued accreditation.
- Other tasks as required by department management.
- Travel may be required.
- Research and interpret client and vendor-supplied documentation in order to write documents.
OTHER DESIRED SKILLS AND EXPERIENCE
- Process Validation
- Sterilization / Autoclave Performance Qualification
- Quality Systems and Remediation
- Implementation of Quality by Design
- Packaging Line Validation
- Cleaning Validation
- QC Lab Commissioning/Qualification/Validation
- Commissioning, Qualification and Validation Generalist (Facilities, Utilities, Process Equipment etc.)
- Strong Attention to Detail
- Proficient in MS Word and MS Excel
- Excellent Communication Skills
- 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
- Primavera Scheduler
- CQV Project Managers