System Validation Specialist
A skilled System Validation Specialist is required to ensure the validation of computerised equipment and systems in a pharmaceutical manufacturing environment. The successful candidate will have experience with CSV validation and be able to work on site with occasional remote working.
Key Responsibilities:
* Validate new computerised equipment and control systems, generating documentation and providing assistance with execution.
* Participate in change control processes, advising on CSV issues as necessary.
* Develop and execute DQ, IQ, OQ and PQ activities, ensuring compliance with regulatory requirements.
* Design and implement validation studies for manufacturing and control equipment, including critical systems and facilities.
* Provide technical assistance on current US FDA and EU validation requirements.
* Maintain validation documentation and ensure compliance with cGMP at all times.
* Approve and implement changes to relevant systems and assist in generating validation/revalidation plans.
Requirements:
* Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering (Chemical/Mech/Electrical).
* 3-5 years' experience in a Healthcare manufacturing environment, ideally in the pharmaceutical sector.
* 2-3 years' experience in a validation environment.