Process Validation Engineer

Process validation engineer required to join a global biotech company for 12 month contract. The process validation engineer will be responsible for ensuring that the Process Validation Activities and Aseptic Process Simulations at the Sterile Manufacturing Site are in compliance with Division Quality System requirements and recognised international standards.

Major Responsibilities:
. Development of Validation Plans, Process Qualifications (PQs), and Process Simulations (Media Fills) for Vial and Syringe Filling.
. Leading the team to ensure all aspects of activity within the Validation group adhere to required policies and procedures, including safety and training.
. Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
. Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
. Generate protocols and reports.
. Pre-approve and post-approve validation support protocols and assessments from a quality system documentation perspective.
. Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
. Collate and report on relevant Validation data/matrices.
. Assist in deviation and exception resolution and root cause analysis.
. Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.
. Participate as required in project activities.
. Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.

Experience/Background
. A third level qualification in Microbiology, Bio-Technology, Science, Engineering or a relevant Quality discipline.
. Minimum 5-7 years' experience in a similar role.

If this is you please apply today.