Job Title: Validation Specialist
A dynamic and experienced Validation Specialist is required to join our team for a 12-month contract. This role involves the validation of all new computerized equipment, control systems, and manufacturing processes.
Key Responsibilities:
* Develop and execute validation protocols for computerized equipment and systems.
* Participate in the change control process advising on CSV issues.
* Manage DQ, IQ, OQ, and PQ activities ensuring compliance with cGMP regulations.
* Provide technical assistance on current US FDA and EU validation requirements.
* Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
Requirements:
* Degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical, Mechanical, or Electrical).
* 3-5 years experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
* 2-3 years experience in validation environment.
Benefits:
* Initially 100% onsite; after the first few months, up to two days per week remote working may be possible (on one of the working days needs to be Monday or Friday).
Role Overview:
This role requires a strong understanding of validation principles, regulatory requirements, and good manufacturing practices (cGMP). As a key member of our team, you will work closely with colleagues to ensure the delivery of high-quality products while maintaining compliance with regulatory standards.