To support current and future projects, ICQ Consultants is actively recruiting Computer System Validation (CSV) Engineers. We currently have multiple opportunities available in 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.
- 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 Computer Systems / Automation Experience.
- 3+ years Process Manufacturing Experience.
- 3+ years Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment.
- Act as a computerized/automated systems project lead.
- Provide quality oversight and compliance support to implement and validate electronic systems in accordance with the client’s computer systems validation procedures and requirements.
- Provide QA oversight during regulatory assessments, risk assessments, 21 CFR Part 11 and Annex 11 assessments.
- Develop or Review Validation Plans, Specifications, Installations Qualification Protocols, Operational Qualification Protocols, Performance Qualifications Protocols, and Summary Reports associated with computer systems.
- Support and review system administration and maintenance procedures to ensure computer systems are in a state of control
- Act in a leadership capacity: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, etc.
DESIRED SKILLS AND EXPERIENCE
- Understanding of GxP and Computer Systems / Automation role in support of GxP compliance is required
- Knowledge and understanding of relevant regulations, such as Part 11, Annex 11, Part 211, etc., is required
- Experience with manufacturing automation systems is highly desired
- Specific experience in Cell Culture, Chromatography, UF/DF, and filtration processes and equipment.
- Previous Project Management Experience.
- Proficiency with Microsoft Office & Delta V.
- 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