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Title

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Validation Engineer

Description

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We are looking for a meticulous and experienced Validation Engineer to join our team. The Validation Engineer will be responsible for planning, implementing, and monitoring the validation strategy in highly regulated industries such as pharmaceuticals, bio-pharmaceuticals, and medical devices. The successful candidate will be responsible for ensuring that all systems and products are working as intended and meet the regulatory requirements. This includes designing and implementing validation schedules, conducting audits, ensuring that all equipment and systems are installed and functioning correctly, and monitoring all software and hardware for compliance with regulatory standards. The Validation Engineer will also be responsible for documenting all validation activities and results, and for ensuring that all staff are trained in the use of validation tools and techniques.

Responsibilities

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  • Designing and implementing validation schedules.
  • Conducting audits and inspections.
  • Ensuring that all equipment and systems are installed and functioning correctly.
  • Monitoring all software and hardware for compliance with regulatory standards.
  • Documenting all validation activities and results.
  • Training staff in the use of validation tools and techniques.
  • Working closely with other departments to ensure that validation processes are effective and efficient.
  • Keeping up to date with changes in regulatory legislation and guidelines.
  • Analyzing and troubleshooting validation results.
  • Reporting to management on validation activities and results.

Requirements

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  • Bachelor's degree in Engineering or a related field.
  • Proven experience as a Validation Engineer.
  • Strong knowledge of validation principles and practices.
  • Excellent problem-solving skills.
  • Strong analytical skills.
  • Excellent communication and interpersonal skills.
  • Strong attention to detail.
  • Good organizational and time-management skills.
  • Ability to work independently and as part of a team.
  • Knowledge of regulatory standards and compliance requirements.

Potential interview questions

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  • Can you describe a time when you had to troubleshoot a validation issue?
  • How do you stay up-to-date with changes in regulatory legislation and guidelines?
  • Can you describe a time when you had to train staff in the use of validation tools and techniques?
  • How do you ensure that all validation activities are documented accurately and thoroughly?