Validation Engineer

Our client, consulting firm in the medical industry, has an immediate need for 2 process Validation Specialists/Consultants for a client in the metro New York City area for a 3+ month contract assignment. The main responsibility for this role is to test and validate and prepare protocols for with the Company's new automated water chiller system that is part of their manufacturing for semi-solid creams and ointment products.

RESPONSIBILITIES

- Write and execute validation protocols for equipment and process operations in relation to GMP (Good Manufacturing Practices) for a new automated chiller system for semi solid liquids (creams, ointments)
- Execute protocols and develop technical validation reports for processes in a pharmaceutical manufacturing facility, processes.
- Ensures all necessary components/resources are available and capable to meet production schedule and established quality standards and goals and that all department operations are in compliance with cGMP/ISO regulations, as well as meeting production standards

REQUIREMENTS

- Bachelor's Degree in Engineering
- 5+ years experience in working in semi-solid pharmaceutical manufacturing
- Experience in developing and following specific project scopes including technical guidance and services related to chiller systems in a pharmaceutical manufacturing environment.
- Understanding of FDA requirements and developing protocols using Good Manufacturing Practices
- Ability to write complex technical reports and regulation position papers
- Be proficient in Microsoft Office, including Word, Excel, PowerPoint
- Knowledge of FDA regulations

BENEFITS

- Medical
- Vacation
- Retirement
- Fully paid expenses to include tolls, meals, hotel and travel to the facility.