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Title
Text copied to clipboard!Validation Specialist
Description
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We are looking for a Validation Specialist to join our team and ensure the accuracy, reliability, and compliance of systems, processes, and documentation across various departments. This role is critical in regulated industries such as pharmaceuticals, biotechnology, and manufacturing, where validation ensures that systems and processes consistently produce results meeting predetermined specifications and quality attributes.
As a Validation Specialist, you will be responsible for developing and executing validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). You will collaborate with cross-functional teams such as Quality Assurance, Engineering, Manufacturing, and IT to ensure that validation activities are completed in accordance with regulatory requirements and company policies.
Your tasks will include preparing validation documentation, conducting risk assessments, reviewing technical specifications, and participating in audits and inspections. You will also be expected to stay current with industry standards and regulatory guidelines, such as FDA, EMA, and ICH, to ensure compliance and best practices.
The ideal candidate will have strong analytical skills, attention to detail, and the ability to manage multiple projects simultaneously. Experience with computer system validation (CSV), equipment validation, and process validation is highly desirable. You should also be comfortable working in a fast-paced environment and possess excellent communication and documentation skills.
This position offers the opportunity to work on cutting-edge technologies and contribute to the development and maintenance of high-quality products and services. If you are passionate about quality, compliance, and continuous improvement, we encourage you to apply for this exciting role.
Responsibilities
Text copied to clipboard!- Develop and execute validation protocols (IQ, OQ, PQ)
- Ensure compliance with regulatory requirements and internal policies
- Collaborate with cross-functional teams to support validation activities
- Conduct risk assessments and impact analyses
- Prepare and review validation documentation
- Participate in audits and regulatory inspections
- Maintain validation master plans and schedules
- Support change control processes
- Troubleshoot validation issues and implement corrective actions
- Stay updated on industry standards and regulatory guidelines
Requirements
Text copied to clipboard!- Bachelor’s degree in science, engineering, or related field
- 2+ years of experience in validation or quality assurance
- Knowledge of FDA, EMA, and ICH guidelines
- Experience with equipment, process, or computer system validation
- Strong analytical and problem-solving skills
- Excellent written and verbal communication skills
- Attention to detail and organizational skills
- Ability to manage multiple projects simultaneously
- Proficiency in Microsoft Office and validation software tools
- Familiarity with GMP, GLP, and GCP standards
Potential interview questions
Text copied to clipboard!- Do you have experience with IQ/OQ/PQ validation protocols?
- Can you describe a validation project you led or contributed to?
- How do you stay current with regulatory changes?
- Have you participated in regulatory audits or inspections?
- What types of systems or equipment have you validated?
- How do you handle discrepancies or deviations during validation?
- Are you familiar with computer system validation (CSV)?
- What validation documentation have you prepared?
- How do you prioritize multiple validation projects?
- What tools or software have you used for validation tracking?
