Senior Engineer, Tech Ops

Responsibilities:

• Lead technology transfer projects across internal manufacturing sites and external partners serving as the technical lead and ensuring successful execution of project deliverables timelines and transfer objectives.
• Provide technical expertise and manufacturing support for process equipment and operational challenges including troubleshooting technical investigations risk assessments and support of commercial manufacturing campaigns.
• Author review and maintain technical documentation including transfer plans assessments procedures batch records protocols specifications reports training materials and related compliance documentation.
• Drive project execution and cross-functional collaboration by coordinating activities across Manufacturing MS&T Quality Engineering Regulatory Supply Chain and external partners including CMOs and CDMOs to achieve project milestones and business objectives.
• Maintain process equipment and automation knowledge to support technology transfer process performance and continuous improvement initiatives that enhance yield reliability robustness safety and operational efficiency
• Support Regulatory and Quality compliance activities through preparation of technical documentation support of submissions and health authority responses and participation in deviations change controls CAPAs OOS OOE and complaint investigations.
• Manage manufacturing readiness activities including material enrollments BOM updates manufacturing system changes and the planning execution and support of engineering demonstration and validation batches to ensure successful process implementation and commercialization across a global manufacturing network.

Qualifications:

• Bachelors degree in a relevant branch of Biological Science or Engineering
• 3-5 years hands-on experience in process development activities
• Knowledge of the regulations (FDA EMEA TGA) associated with GMP production
• Pharmaceutical/biotech experience preferred
• Different qualifications or responsibilities may apply based on local legal and/or educational requirements.
• Refer to local job documentation where applicable.

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

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At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

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CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit our On the Front Line video to learn more about CSL Seqirus