Validation Engineer

4 weken geleden

Leiden, Nederland Oxford Global Resources Voltijd

Join as a Validation Specialist in our medical oncology team, focusing on Qualification processes. Exciting international role with cutting-edge tech, competitive pay, and significant responsibility. Want to learn more

Job Description

As a Validation Engineer, you'll be an essential part of our dynamic team, specializing in Pharma, GMP, and validation processes (CP/IQ/OQ/PQ). Your key responsibility is to ensure adherence to regulatory standards and support initiatives in a fast-paced environment. This involves executing specialized tasks related to regulatory compliance, such as developing and implementing commissioning and qualification protocols. Additionally, you'll oversee various regulatory activities such as temperature mapping and investigating and applying corrective measures for compliance deviations. Collaborating closely with Quality Engineering, you'll help formulate strategies and protocols for regulatory compliance. This role presents a unique opportunity to contribute to cutting-edge immunotherapy treatments for cancer within an international setting. With front-line operational technical support, competitive pay, and a significant level of responsibility, this position offers promising opportunities for growth and fulfilment.

Responsibilities

  • Integral role as a Validation Engineer specializing in Pharma, GMP, and validation processes.
  • Focus on ensuring regulatory compliance and supporting initiatives in a fast-paced environment.
  • Develop CSV documents: Risk Assessments, Validation Plans, User Tests, and Reports for computerized systems.
  • Execute tasks such as developing and implementing commissioning and qualification protocols.
  • Oversee activities including temperature mapping and applying corrective measures for compliance deviations.
  • Collaborate with Quality Engineering to formulate strategies for regulatory compliance.
  • Unique opportunity to contribute to cutting-edge immunotherapy treatments for cancer in an international setting.
  • Competitive pay and significant responsibility await in this dynamic role.

Requirements

  • Minimum of MBO, 6+ years or HBO + 4 years of relevant experience.
  • Proficiency in GMP (Good Manufacturing Practices) and regulatory compliance.
  • Strong attention to detail and problem-solving skills.
  • Excellent communication and interpersonal abilities.
  • Ability to work effectively both independently and as part of a team.
  • Familiarity with commissioning, qualification protocols, and regulatory compliance procedures.
  • Experience in managing equipment calibration and certification is preferred.
  • Prior experience in preparing documentation for regulatory compliance is advantageous.
  • Fluency in English is required.

Benefits

  • Contract of 6 months with possibility for extension
  • Competitive Dayshift salary package (~ 5000/Month)
  • Region: Leiden
  • Vacaturenummer: 24407

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