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Validation Engineer
Eingestellt von Optimus Search
Gesuchte Skills: Engineer, Engineering, Client
Projektbeschreibung
VALIDATION ENGINEER - SWITZERLAND - 6 MONTHS - €80P/H
Optimus Life Sciences are working with a global Pharmaceutical company based in Switzerland. My client is seeking a validation engineer to execute protocols to demonstrate that manufacturing and cleaning processes are carried out with consistent quality. As a validation engineer you will also be engineering studies to evaluate new products or components, change control assessments, and coordination of computer and method validations of applicable products.
RESPONSIBILITIES
- Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols
- Develop timelines for all projects and ensure that deadlines and goals are being met. Frequently update management and team on progress
- IQ/OQ/PQ duties
- Compile and analyse validation data, prepare reports, and make recommendations for changes and/or improvements.
REQUIREMENTS
- At least 5 years of validation experience in a cGMP environment
- At least 5 years experience with validations in controlled environments or equipment validations in a regulated environment.
- Experience with validation documentation and related change control
- Validation experience in a pharmaceutical or Medical Device manufacturing environment.
- Experience with NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) products.
- Six Sigma certification
Optimus Life Sciences are working with a global Pharmaceutical company based in Switzerland. My client is seeking a validation engineer to execute protocols to demonstrate that manufacturing and cleaning processes are carried out with consistent quality. As a validation engineer you will also be engineering studies to evaluate new products or components, change control assessments, and coordination of computer and method validations of applicable products.
RESPONSIBILITIES
- Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols
- Develop timelines for all projects and ensure that deadlines and goals are being met. Frequently update management and team on progress
- IQ/OQ/PQ duties
- Compile and analyse validation data, prepare reports, and make recommendations for changes and/or improvements.
REQUIREMENTS
- At least 5 years of validation experience in a cGMP environment
- At least 5 years experience with validations in controlled environments or equipment validations in a regulated environment.
- Experience with validation documentation and related change control
- Validation experience in a pharmaceutical or Medical Device manufacturing environment.
- Experience with NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) products.
- Six Sigma certification
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik