> key skills: a strong understanding of process validation principles,,

Job Title: Process Validation Specialist


We are seeking a highly skilled Process Validation Specialist to support our site requalification program. This is a 12-month contracting position that requires the candidate to have experience working in a healthcare manufacturing environment, preferably within the pharmaceutical sector.




About This Role


The Process Validation Specialist will be responsible for designing, executing and reporting on periodic qualification programs. They must ensure that qualification studies are managed in conjunction with all required standards and legal requirements, including cGMP, Health & Safety, construction, environmental etc.




Main Responsibilities:
* Designing and executing periodic qualification programs;
* Evaluating validation status of equipment and systems to ensure compliance with cGMP at all times;
* Maintaining knowledge of current US FDA and EU validation requirements for aseptic processing, lyophilisation sterilization and depyrogenation;