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Title
Text copied to clipboard!Validation Engineer
Description
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We are looking for a dedicated and detail-oriented Validation Engineer to join our dynamic team. The Validation Engineer will play a critical role in ensuring that our systems, equipment, and processes comply with regulatory standards and internal quality requirements. This position involves developing, executing, and documenting validation protocols and reports, as well as collaborating closely with cross-functional teams to ensure compliance and efficiency.
The ideal candidate will have a strong background in engineering principles, validation methodologies, and regulatory compliance. You will be responsible for planning and conducting validation activities, including equipment qualification, process validation, cleaning validation, and computer system validation. You will also be expected to identify and resolve validation issues, ensuring that all validation activities are completed accurately and on schedule.
In this role, you will collaborate with quality assurance, manufacturing, engineering, and regulatory affairs teams to ensure that validation activities align with company policies and regulatory requirements. You will also be responsible for maintaining validation documentation, preparing validation reports, and participating in audits and inspections.
The successful candidate must possess excellent analytical and problem-solving skills, strong attention to detail, and the ability to manage multiple projects simultaneously. You should be comfortable working independently as well as part of a team, and have excellent communication and interpersonal skills.
As a Validation Engineer, you will stay current with industry trends, regulatory changes, and best practices in validation and quality assurance. You will provide guidance and training to team members on validation procedures and regulatory requirements, ensuring that the organization maintains compliance and continuously improves its validation processes.
This position offers an exciting opportunity to contribute to the success of our organization by ensuring the quality, safety, and compliance of our products and processes. If you are passionate about validation engineering and committed to excellence, we encourage you to apply and become a valuable member of our team.
Responsibilities
Text copied to clipboard!- Develop and execute validation protocols and reports for equipment, processes, and systems.
- Collaborate with cross-functional teams to ensure compliance with regulatory standards and internal quality requirements.
- Identify, investigate, and resolve validation issues and deviations.
- Maintain accurate and comprehensive validation documentation and records.
- Participate in internal and external audits and inspections related to validation activities.
- Provide training and guidance to team members on validation procedures and regulatory requirements.
- Stay current with industry trends, regulatory changes, and best practices in validation engineering.
Requirements
Text copied to clipboard!- Bachelor's degree in Engineering, Science, or related technical field.
- Minimum of 3 years of experience in validation engineering or related role.
- Strong knowledge of validation methodologies, regulatory requirements, and quality standards.
- Excellent analytical, problem-solving, and organizational skills.
- Ability to manage multiple projects simultaneously and meet deadlines.
- Strong communication and interpersonal skills.
- Proficiency in validation software tools and Microsoft Office applications.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with developing and executing validation protocols?
- How do you ensure compliance with regulatory standards during validation activities?
- Can you provide an example of a validation issue you encountered and how you resolved it?
- What validation methodologies and tools are you most familiar with?
- How do you stay current with industry trends and regulatory changes in validation engineering?
