Technology Transfer Engineer III

CSL

4

(1)

Holly Springs, NC

Why you should apply for a job to CSL:

  • 4/5 in overall job satisfaction
  • Ratings are based on anonymous reviews by Fairygodboss members.

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    Position summary

    n Holly Springs, NC location Monday-Friday during primary business hours. Benefits Include flexible hours M-F, Onsite Café, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

    Responsibilities:

    • Provide support to the product transfer team as the primary point of contact for technical and operational equipment/process issues. Define, scope, execute and when needed troubleshoot and investigate equipment/product problems in the manufacturing facility while coordinating with appropriate teams to resolve issues and prevent reoccurrence.

    • Provide technical information for process-related matters within the transfer team to maximize process understanding and enhance knowledge-based decision making.

    • Provide technical support pertaining to technology transfer. Lead technical discussions among stakeholders and coordinate activities to transfer the technical aspects of the manufacturing process in line with the project schedule.

    • Draft and provide ownership of manufacturing documentation (assessments, procedures, studies, protocols, records, specifications, etc.). This function involves creating, revising, and withdrawing documentation, including ownership of related compliance actions.

    • Maintain knowledge on the relationship between the process, the equipment, and the automation at the sending site to receiving site. Identify continuous improvement activities to improve performance.

    • Ensure that equipment and process improvements are provided to the project team and when applicable applied to CMOs. Coordinate with local area SMEs to ensure historical knowledge and equipment understanding is applied to the process being transferred.

    • Assist with investigations related to product and process including complaints, out of expectation, out of specification, etc during the transfer process.

    • Complete source documents and regulatory sections for new and updated filings, as well as, provide SME responses to market authority questions through approval of tech transfer

    Qualifications:

    • Bachelor degree or equivalent, or equivalent vocational or technical education

    • Knowledge of production operation

    • Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required

    • 5 years' experience in manufacturing

    Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

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    Our Benefits

    CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.

    Please take the time to review our benefits site to see what's available to you as a CSL Seqirus employee.
    About CSL Seqirus
    CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.

    We want CSL Seqirus to reflect the world around us

    As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.

    Do work that matters at CSL Seqirus!

    Watch our 'On the Front Line' video to learn more about CSL Seqirus

    Why you should apply for a job to CSL:

  • 4/5 in overall job satisfaction
  • Ratings are based on anonymous reviews by Fairygodboss members.