Validation Engineer

Location: Hoofddorp, Noord-Holland  |  Sector: Biotechnology  |  Start Date: 5/13/2024  |  Job ref: 52686

The company
As a pioneering bio-pharmaceutical company at the forefront of cancer immunotherapy, this company is dedicated to developing innovative and transformative treatments. Joining the team means becoming part of a cutting-edge organization committed to revolutionizing cancer care.

Role Description
As Validation Engineer at this company, your role revolves around ensuring the validation and compliance of various systems and processes within the organization. This entails executing validation protocols, conducting investigations, managing documentation, and collaborating with cross-functional teams to maintain quality standards and regulatory requirements. Additionally, you’ll play a crucial role in commissioning, qualification, and validation projects while providing guidance and support throughout the project lifecycle.

Responsibilities
– Develop and implement commissioning, qualification, and validation protocols (CP/IQ/OQ/PQ), ensuring the detection and resolution of any anomalies or exceptional circumstances.
-Conduct temperature mapping and various additional validation tasks as needed.
-Perform investigations and implement corrective actions related to protocol Exceptional Conditions.
-Develop Computerized System Validation (CSV) documentation, comprising computerized system Risk Assessments, Validation Project Plans, User Acceptance Tests, and Reports.
-Offer guidance and execute commissioning and qualification strategies for computerized systems, equipment, utility systems, and facilities during project planning and development stages.
-Examine technical documentation, including protocols and summary reports for Computerized System Validation (CSV) and Commissioning, Qualification & Validation (CQV) lifecycle documentation, along with other testing and validation Standard Operating Procedures (SOPs).
-Perform investigations and implement corrective actions related to CAPAs and deviations.

Requirements
-Minimum 4 years of experience in validation engineering
-Experience in the pharmaceutical industry/GMP

Other information
Apply to our vacancy for more information. looking forward to hearing from you!
 

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