Top 20 USA Jobs Validation Engineer || Brea, CA (Hybrid) || Local to CA || Contract Quick Apply

The role of a Validation Engineer involves ensuring that systems, processes, and products meet regulatory and quality standards. Here are the top 20 job responsibilities of a Validation Engineer:

1. Validation Planning:
   • Develop validation plans outlining the scope, approach, resources, and schedule for validation activities.
2. Requirements Analysis:
   • Review and analyze user and system requirements to define validation criteria.
3. Test Protocol Development:
   • Create and execute test protocols for equipment, processes, and systems validation.
4. Risk Assessment:
   • Conduct risk assessments to identify potential validation issues and develop mitigation strategies.
5. Change Control:
   • Manage change control processes related to validated systems, ensuring compliance with regulations.
6. Validation Documentation:
   • Generate and maintain validation documentation, including test scripts, reports, and traceability matrices.
7. IQ/OQ/PQ Execution:
   • Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
8. Data Integrity:
   • Ensure data integrity and accuracy during validation activities, adhering to regulatory requirements.
9. Validation Protocols Review:
   • Review and approve validation protocols and reports generated by other team members.
10. Validation Compliance:
    • Ensure that validation activities comply with relevant regulatory requirements, such as FDA, GMP, and ISO standards.
11. Equipment Qualification:
    • Qualify manufacturing and laboratory equipment to ensure proper functionality and performance.

1. CSV (Computer System Validation):
   • Perform computer system validation for software applications used in regulated processes.
2. Training:
   • Provide training to personnel involved in validation activities and ensure awareness of compliance requirements.
3. Validation Execution Oversight:
   • Oversee the execution of validation activities, coordinating with cross-functional teams.
4. CAPA (Corrective and Preventive Actions):
   • Contribute to the investigation and resolution of deviations and non-conformances related to validation activities.
5. Audit Support:
   • Support internal and external audits related to validation processes and documentation.
6. Validation Master Plans:
   • Develop and maintain Validation Master Plans outlining the overall strategy for validation activities.
7. Vendor Qualification:
   • Qualify and manage vendors providing equipment or systems related to the validation process.
8. Continuous Improvement:
   • Identify opportunities for process improvements within the validation function.
9. Validation Status Reporting:
   • Provide regular status updates on validation activities to management and relevant stakeholders.

Validation Engineers play a crucial role in ensuring the reliability, safety, and compliance of processes and systems within regulated industries such as pharmaceuticals, biotechnology, medical devices, and manufacturing. They work to establish and maintain validation processes that meet industry standards and regulatory requirements.