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Equipment Validation Specialist
3 weeks ago
Job Overview:
This is an exciting opportunity for a skilled validation professional to join our team and play a key role in ensuring the quality and reliability of our computerised equipment and control systems.
Key Responsibilities:
- Develop and execute comprehensive validation strategies for new computerised equipment and control systems, including generating documentation and providing assistance with protocol execution.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements, industry standards, and organisational policies.
- Design, implement, and execute DQ, IQ, OQ, and PQ activities to verify the performance and functionality of equipment and systems.
- Conduct thorough risk assessments to identify potential vulnerabilities and develop mitigation strategies to ensure the integrity of our processes.
- Provide technical expertise on US FDA and EU validation requirements for lyophilization, aseptic processing, and sterilisation.
- Maintain accurate and detailed records of validation activities, including approving and implementing changes to relevant systems and generating validation/revalidation plans.
Requirements:
- Degree in Science (Chemistry, Micro., or Pharmacy) or Engineering (Chemical/Mech/Elec).
- Minimum 3-5 years of experience working in a Healthcare manufacturing environment, preferably in the pharmaceutical sector.
- 2-3 years of experience in a validation environment, with a strong understanding of regulatory requirements and industry standards.
