Job Description

Must Haves:

• Bachelor’s degree in Engineering or related field
• 3+ years of experience as a Computer Validation Engineer or Laboratory Validation support role
• Knowledge of validation principles and industry-specific regulations (e.g., FDA, cGMP).
• Experience with computer system validation (CSV) processes, including planning, specifications, preparation, testing, documentation, and operation.
• Excellent communication and teamwork skills.
• Proficiency with validation software tools.
• Ability to document and report technical information accurately.

Pluses:

• Master's Degree in Engineering or related field
• Pharmaceutical manufacturing experience

Job Description:

We are seeking a skilled and detail-oriented Laboratory Validation Support Engineer to join our team. The primary responsibility of this role is to ensure that all laboratory systems and equipment are validated and compliant with regulatory standards, with a strong emphasis on documentation. The ideal candidate will have a strong technical background in pharmaceutical processes, computer system validation (CSV), and a keen eye for detail.

Responsibilities:

• Develop and execute validation protocols for laboratory equipment, systems, and processes.
• Conduct validation tests and analyze results to ensure compliance with internal and external regulations.
• Document all validation processes and test results for future reference and audits.
• Identify potential issues or malfunctions and develop solutions to address them.
• Update and maintain validation protocols and standard operating procedures (SOPs).
• Train staff on validation procedures and protocols.
• Review and approve validation reports.
• Stay up-to-date with the latest industry trends and regulatory standards.
• Collaborate with validation engineers, quality assurance (QA) teams, and documentation specialists to ensure comprehensive validation coverage and compliance.
• Support change control activities by assessing the impact of changes on validated systems and processes, and ensuring that all changes are properly documented and validated.
• Focus on creating, updating, and maintaining comprehensive documentation for all laboratory validation activities.
• Utilize PDOCs and Kneat software systems for electronic documentation and validation management

Job Tags

Similar Jobs