Ready to join a team committed to moving gene therapies into the clinical setting for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101. We are at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.
The Process Engineer/System Owner is responsible for providing engineering and maintenance support to the downstream and fill/finish manufacturing area. This individual shall have a strong understanding of GMP’s and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility. Equipment may include chromatography, tangential flow filtration, filling, labeling, and visual inspection.
This individual will be required to develop an understanding of current and future processes and translate these into the facility and equipment requirements at the Libertyville manufacturing site.
Primary responsibilities include ensuring the equipment and processes runs in a compliant manner. Investigate any equipment or process deviations and develop corrective actions to prevent reoccurrences. Work collaboratively with staff for the development of user requirements and functional specifications. Responsible for either leading or proving SME support on capital related projects.
• Owns and manages changes to the process equipment
• Maintains equipment in a validated state • Problem solve any technically related issues impacting production
• Prepare contingency plans and logically work through complex issues
• Develop and implement equipment reliability and maintenance strategies that are compliant, effective and cost appropriate
• Develops project objectives working with user requirement and business plans
• Determines project specifications and cost effective technology’s to be implemented
• Establish equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS)
• Review and approve critical documentation such as SOP’s and URS’s
• Participate in all FDA and internal audits of the manufacturing facilities and process equipment and respond to any observations received
• Responsible for maintaining quality standards to meet GMP requirements, CFR’s and internal company policies
• Participate in new product introduction
• Drive operational excellence and continuous improvement
• Minimum B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, or 4 years of equivalent work experience AND
• A minimum of 4 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish
• Experience in the development, automation, and manufacture of gene therapy products, medical devices, instruments, or biotechnology
• In-depth knowledge of FDA regulations and GMP systems
• Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high quality processes and end products
• Excellent oral and written communication skills. Strong technical writing ability required
Approximately 10% travel required
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.