
Data Validation Specialist
2 weeks ago
We are seeking a skilled Data Validation Specialist to join our team. As a CSV Engineer, you will be responsible for ensuring the validation and compliance of computerized equipment and systems in sterile pharmaceutical manufacturing environments.
Key Responsibilities:- Develop and execute validation protocols (DQ, IQ, OQ, PQ) for computerized equipment and control systems.
- Generate and review validation documentation, including protocols, reports, and revalidation plans.
- Provide technical expertise on current FDA and EU validation requirements, particularly for lyophilization, aseptic processing, and sterilization.
- Participate in the change control process, advising on CSV-related matters.
- Ensure compliance with cGMP, health, safety, and environmental regulations.
- Troubleshoot validation issues and provide solutions during project execution.
- Review and approve site change controls and ensure validation status aligns with regulatory expectations.
- Collaborate with cross-functional teams to ensure project timelines and quality standards are met.
To succeed in this role, you will need:
- A degree in Science (e.g., Chemistry, Microbiology, Pharmacy) or Engineering (e.g., Chemical, Mechanical, Electrical).
- A strong understanding of GAMP, ISPE Baseline Guides, and quality management systems.
- Hands-on experience in validation activities within a healthcare or pharmaceutical manufacturing environment.
- Knowledge of cGMP regulations and compliance requirements.
- Effective communication and facilitation skills across teams and organizational levels.
- The ability to manage projects effectively and meet key performance indicators (KPIs).
- A problem-solving mindset with adaptability and resilience.
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