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Validation Engineer

Eingestellt von Randstad Engineering

Gesuchte Skills: Engineering, Consultants, Engineer

Projektbeschreibung

Validation Specialists / Consultants are needed to test, validate, and prepare protocols for new automated water chiller system for a client in the metro New York City manufacturing semi-solid creams and ointment products. 3+ month contract assignment with per diem available.

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.

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Randstad Engineering