To support current and future projects, ICQ Consultants is actively recruiting Cleaning Validation Subject Matter Experts. We currently have multiple opportunities available in the Greater Boston Area.
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.
- 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:
- 5+ years Process Manufacturing Experience.
- 5+ years Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment.
- Generate, review, approve, and execute process, facility, and cleaning validations.
- Supports the facility equipment cleaning validation program, creates and maintains SOPs for cleaning validation program.
- Assist engineering with equipment qualifications by participating in FATs, commissioning activities, SATs, and IOPQ events.
- Conducts or coordinates performance qualification execution for new or existing equipment.
- Active 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
- Considered a Subject Matter Expert (SME) in cleaning validation.
- Specific experience in Cell Culture, Chromatography, UF/DF, and filtration processes and equipment.
- Previous Project Management Experience.
- Proficiency with Microsoft Office & Delta V.
- Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
- Excellent Communication Skills.
- Ability to handle many tasks with limited direction.
- 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 firstname.lastname@example.org