Job Description

The validation team at Seqirus are looking to recruit an experienced validation specialist to work within the fill finish project team to support qualification of filling, inspection and packaging equipment and processes. To co-ordinate the validation activities, focusing on Equipment Qualification and validation of secondary processes, to ensure that the appropriate site and regulatory standards are applied, and work is completed in a timely manner

• Lead and perform small to medium size validation activities by writing, reviewing, approving and executing documentation for new and current validation activities. Generating validation technical reports related to systems, products and/or processes, in compliance with company standards and regulatory requirements.
• Co-ordination of validation studies - ensuring pre-requisite activities are completed, required resources and support functions are available to execute the tasks
• Maintain the validated status by fulfilling re-validation and re-evaluation requirements, and be responsible for VMP maintenance in nominated areas.
• Provide technical leadership, and investigate/troubleshoot validation problems. Conduct statistical analyses of testing results and process anomalies and ensures that corrective measures meet acceptable standards.
• Assist with establishing, updating and reviewing local and global validation procedures.
• Assists in developing programs and maintaining standard operating procedures (SOPs)
• May provide support related to management of procedural documents, the Learning Management System (LMS) and GxP training
• Communicates cross functionally regarding needs and status of assigned study activities and project deliverables

Bachelor degree in engineering, mathematics or a relevant scientific discipline (chemistry, biology, microbiology, etc.)

5 years\' related quality/validation experience in pharmaceutical manufacturing/a highly regulated industry

The following would be desirable

• Experience in validation of secondary processes associated with filling lines and isolators such as Vapourised Hydrogen Peroxide (VHP), Clean In Place (CIP), Steam Sterilisation In Place (SIP), Aseptic Process Simulations and Process Performance Qualification (PPQ)
• Experience in Automatic Inspection Machine qualification
• Experience in Packaging Line Equipment Qualification
• Experience in Serialisation Qualification

About Us

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world\'s largest collectors of human plasma, which is used to create CSL\'s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

CSL