ICQ is recruiting Experienced CQV Engineers in Southern New England.

If you are considering a career change, we would love to hear from you.  ICQ is actively recruiting highly motivated professionals to join our team.  We currently have multiple opportunities available in Southern New England.

ICQ offers some of the most competitive benefits and wages in our segment of service providers which include the following:

    • Tufts Health Insurance, Delta Dental  – Paid 100% by ICQ, no employee premium.
    • Paid time off for Holidays, Sick Time and Vacation
    • 401K with a 100% match up to 4%
    • Short term / Long Term Disability – Paid 100% by ICQ
    • Life insurance – Paid 100% by ICQ
    • Reimbursed Project Specific Travel & Business Expenses 

Positions report to the assigned manager and applicants are responsible for developing and executing protocols, including test functions, calibration, and sampling.  Must maintain compliance with the company’s Standard Operating Procedures and Policies.

EDUCATION/EXPERIENCE REQUIREMENTS

  • B.S. degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
  • Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving in one or more of the following:
    • 3+ years Process Manufacturing Experience.
    • 3+ years Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment.

RESPONSIBILITIES

  • Develop and publish new validation project plans and protocols, execute protocols and write final reports with little supervision.
  • Perform hands-on execution of Installation, Operational and Performance Qualifications for equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing processes in accordance with predefined test protocols.
  • Actively participate in field/site activities including attending FATs and SATs, as well as vendor start-up and testing activities.
  • Perform walk down and verification of system drawings.
  • Actively manage resources associated with test plans and protocol execution.
  • Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
  • 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.

DESIRED SKILLS AND EXPERIENCE

  • Equipment Validation Experience (bioreactors, mixers, filtration, incubators, refrigerators/freezers, cold rooms).
  • Utility System Validation Experience (water systems, compressed gases, clean steam, SIP, CIP, COP, electrical, HVAC)
  • Specific process experience related to Cell Culture, Chromatography, UF/DF, and media/buffer prep processes.
  • Ability to function as a Technical Equipment and Utility Validation Lead.
  • Previous Project Management Experience.
  • Proficient in Microsoft Office.
  • Excellent Communication Skills.
  • Ability to deliver results is a must.

Only local candidates will be considered.

If you are interested in learning more about current opportunities, contact us directly at [email protected]