Csv Engineer
We are seeking a skilled Csv Engineer to join our team. The successful candidate will play a pivotal role in ensuring the ongoing validation compliance of computerised equipment and systems in sterile products manufacturing.
Job Description:
* Integrate into the validation process for all new computerised equipment, and control systems, generating thorough documentation and providing assistance with protocol execution.
* Participate in change control processes, offering advice on Csv issues as necessary.
* Engage in development and execution of DQ, IQ, OQ, and PQ activities, maintaining project compliance with Company and legal requirements.
Responsibilities:
1. Develop and implement validation studies for manufacturing and control equipment.
2. Provide technical expertise on current US FDA and EU validation requirements for lyophilization, aseptic processing, and sterilisation.
3. Maintain validation status compliance with c GMP at all times.
Qualifications:
* Degree in Science (Chemistry, Micro).
* Possess strong knowledge of c GMP regulations.
* Excellent analytical skills.