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Validation Engineer
Eingestellt von Randstad Engineering
Gesuchte Skills: Engineering, Consultants, Engineer
Projektbeschreibung
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
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Einsatzort:
New York, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Organisation/Management