cGMP Utilities Engineer
Ready to join a team committed to moving gene therapies into the clinical and commercial settings 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 in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.
AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.
The Process Engineer is responsible for providing engineering and maintenance support to the facility area and HVAC manufacturing. This individual must have a strong understanding of GMPs and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility. Equipment may include air handlers, portable cleanrooms, electrical systems, UPS, Generators, and gas switching stations.
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 manufacturing site.
Primary responsibilities include ensuring the equipment and processes runs in a compliant manner, investigating any equipment or process deviations and developing corrective actions to prevent reoccurrences.
- 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.
- Work collaboratively with staff for the development of user requirements and functional specifications.
- 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.
- Maintain quality standards to meet GMP requirements, CFR's and internal company policies.
- Participate in new product introduction.
- Drive operational excellence and continuous improvement.
- Lead or provide subject matter expertise on capital related projects.
- Bachelor's degree in Chemical, Electrical or Mechanical Engineering, or related technical field, or 4 years of equivalent work experience
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 with a strong technical writing ability.
Approximately 10% travel required.
The level of this position will be based on the final candidate's qualifications.
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.