
Verification Specialist
6 days ago
Validation Expertise
About the RoleThe successful candidate will play a vital role in ensuring the quality and reliability of equipment, facilities, and processes. As a Validation Engineer, you will be responsible for Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering to meet regulatory requirements and industry standards.
Key Responsibilities- Develop and execute commissioning, qualification, and validation protocols for equipment, facilities, utilities, and processes.
- Execute computer system validation activities, including defining user requirements, developing test scripts, and conducting validation testing.
- Collaborate with cross-functional teams to ensure that systems and processes meet regulatory and quality standards.
- Perform risk assessments and develop validation plans to mitigate potential risks.
- Generate and maintain validation documentation, including protocols, reports, and standard operating procedures (SOPs).
- Participate in change control processes to assess the impact of changes on validated systems.
- Investigate and resolve deviations related to validation activities, ensuring compliance with regulatory requirements.
- Proactively identify opportunities for process improvements in validation activities.
- Stay abreast of industry trends, regulatory changes, and best practices related to CQV and CSV.
- Bachelor's degree in Engineering or related technical field.
- Minimum of 3-5 years of validation engineering experience in the pharmaceutical industry.
- Demonstrated experience in both Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering.
- Strong technical writing and documentation skills.
- Strong understanding of regulatory requirements, Data Integrity, 21 CFR Part 11 Compliance, GAMP 1-4 or 5.
- Experience with risk-based validation approaches and methodologies.
- Excellent analytical and problem-solving skills.
- Effective communication and interpersonal skills.
- Detail-oriented with strong organizational abilities.
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