Validation Engineering Specialist I

at  Thermo Fisher Scientific

SUMMARY:

Provides specialized knowledge and information, which is directly needed to support operations. Completes protocols and reports related to the validation of manufacturing processes, packaging processes and cleaning. Review all finished reports prior to final approval. Ensure documents conform to all ThermoFisher Standard Operating Procedures (SOPs), client requirements and Good Manufacturing Practices.

EDUCATION:

Minimum post secondary diploma in Chemistry, Engineering, Science or related field.

EXPERIENCE:

One year related experience in the pharmaceutical industry.

ESSENTIAL FUNCTIONS:

• Prepare and execute validation protocols (new and existing clients) and write reports.
• Review/verify data and performs statistical analysis.
• Monitor the production scheduling and coordination of validation activities as required
• Attend client meetings as validation representative.
• Provide technical/validation expertise and support to Quality Operations/Business or Project management/operations/Pharmaceutics and Process Technology (PPT).
• Document review of peer protocols and reports.
• Maintain cleaning program and trending cleaning results.
• Support equipment swabbing.
• Attend client meetings as validation representative (as required)
• Support special projects (as required)
• Maintain a safe working environment and report potential hazards.
• Perform alternating or rotating shifts (if required)