Job Title: Engineers/Consultants in the Boston Area for QC Lab Validation, Cleaning Validation, Commissioning, Qualification and Validation
Teams of Integrated Commissioning & Qualification Corporation (ICQ) Consultants have played a central role in developing and executing various quality systems as well as the commissioning and qualification of multiple manufacturing plants in the New England area and elsewhere, including some of the world’s largest biotechnology facilities. Now due to our ever increasing client base we are looking for other professionals to join our team.
ICQ offers some of the most competitive benefits and wages in our segment of service providers which include the following:
- Short term / Long Term Disability – Paid 100% by ICQ
- Life insurance – Paid 100% by ICQ
- Blue Cross Blue Shield Health Insurance, Dental and Vision Plan – Paid 100% by ICQ
- Paid time off for Holidays, Sick Time and Vacation
- 401K with a 100% match to the first 4%
…and much more. There’s a reason we are one of the largest and most sought after CQV suppliers in the Northeast and now Southeast so select to follow us on LinkedIn.
GENERAL RESPONSIBILITIES AND REPORTING
This position reports to the assigned manager and is responsible for developing and executing protocols, including test functions, calibration, and sampling. Must maintain compliance with the company’s Standard Operating Procedures and Policies.
- BS/BA degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
- Knowledge of FDA requirements, including cGMP’s, Quality System Remediation and Quality by Design, ICH-Q9, ICH-Q10, ASTM E-2500 principles.
- 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 to 5 years QC Lab Validation Experience.
- 2 to 5 years Cleaning Validation
- 2 to 5 years Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment
- Develop and execute validation plans, test plans, validation protocols, and procedures.
- Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
- Work as a leader, part of 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.
Desired Skills and Experience
- QC Lab Commissioning/Qualification/Validation
- Cleaning Validation
- Commissioning, Qualification and Validation Generalist (Facilities, Utilities, Process Equipment etc.)
- Strong Attention to Detail
- Proficient at 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