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Technology Transfer Engineer III
3 months ago
Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.
As the Engineer, Technology Transfer, you will be reporting to the MS&T Technical Solutions Leader and will work onsite at our CSL Seqirus in 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.
#LI-Onsite
Our BenefitsCSL 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 usAs 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 SeqirusWatch our ‘On the Front Line’ video to learn more about CSL Seqirus
