Job: MS&T Engineer III (Continuous Process Verification), Seqirus, Holly Springs, NC
Come join 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 the state of the art manufacturing facility and a deep 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.
The incumbent will be part of the Manufacturing Sciences & Technology, Process Sciences team at the Holly Springs cell culture Influenza Vaccine manufacturing facility, supporting Bulk and/or Fill-Finish Operations. The MS&T function provides strategic technical direction to manufacturing organizations (including 3rd parties) to achieve supply targets and maximize capacity. This position has responsibilities that include providing technical expertise related to the process, equipment, and business systems that support Bulk Cell Culture, Fill-Finish, or Technology Transfer t
Manage and maintain the Holly Springs Continuous Process Verification (CPV) program for drug substance and drug product.
Manage and maintain process monitoring tools (connected to OSI Pi, LIMS, SAP, etc.)
Manages updates to parameters alert and alarm limits
Authors Annual Product Reviews and contributes to Product Quality Review for analysis and for contributing to process technology innovations.
Technical Expert for global improvement programs for data and analytics
Technical Expert for multiple assigned unit operations and processes in the cell culture, protein harvest, protein purification, and protein formulation areas. Responsible for the reliability and robustness of assigned products and/or processes.
Identifies and leads implementation of complex continuous improvement projects to improve yield, reliability, and process robustness.
Leads the execution of process validations, annual monitoring batches, and short-term improvement projects, liaising with all the relevant parties to ensure accurate execution
Lead complex product and process related investigations and deviations including complaints, Out Of Expectation, Out Of Specification.
Provide input to internal and regulatory audits as appropriate, serving as a lead SME during audits.
Provide front line support to Manufacturing during qualification of new equipment or validation of new processes. Lead technical expert during execution of related activities.
Develops, maintains, and analyzes departmental metrics and key performance indicators (KPIs).
Provide technical information and support training for process-related matters within production to maximize process understanding and enhance knowledge-based decision making.
Ensure protocols are executed as intended and oversee execution of protocols.
Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures.
Drives continuous improvement initiatives to proactively prevent process failures. Leverages process and compliance expertise to facilitate cross functional decision making and strategy alignment.
Maintains depth and breadth of knowledge on the relationship between the process, the equipment, and the automation in the facility.
Process and equipment owners, providing fit-for-purpose risk assessments for technology transfers.
Troubleshoots and investigates equipment problems in the facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence.
Bachelor’s degree required. Degree in Engineering or Science
7+ years’ related experience required OR equivalent, including 4+ years’ experience in biopharmaceutical operations working in a technical role. Or, 5 years’ experience + Master’s Degree in applicable field.
Strong experience and knowledge of cell culture, protein harvest, and/or protein purification production.
Advanced knowledge of Excel and OSIsoft Pi
Experience with cell culture manufacturing preferred.
Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required, with direct experience supporting biannual or pre-approval inspections.
Must have strong communication skills and good attention to detail.
Must be flexible, able to multi-task in a fast-paced environment, and operate well in a team setting.
A solid understanding of engineering and/or scientific principles and the ability to apply your knowledge.
Advanced troubleshooting skills with ability to mentor others.
Excellent organizational, planning and time management skills.
The ability to work effectively in both a team environment and an individual contributor role