Process Engineer - CMO Partnerships
Company: AveXis Inc.
Posted on: October 12, 2019
OverviewReady to join a team committed to developing and
commercializing gene therapies for patients and families devastated
by rare neurological genetic diseases? AveXis is advancing
cutting-edge science, starting with our proprietary gene therapy
for the treatment of spinal muscular atrophy (SMA). We are in the
midst of an incredible journey and are looking for passionate
individuals to join us on this important mission.AveXis, a Novartis
company, is dedicated to developing and commercializing novel
treatments for patients suffering from rare and life-threatening
neurological genetic diseases. Our initial product is a proprietary
gene therapy approved by the US Food and Drug Administration for
the treatment of pediatric patients with SMA. In addition to
developing a treatment for SMA, AveXis also plans to develop other
novel treatments for rare neurological diseases, including Rett
syndrome and a genetic form of amyotrophic lateral sclerosis caused
by mutations in the superoxide dismutase 1 (SOD1) gene.The Process
Engineer is responsible for providing engineering, validation and
maintenance support to the process manufacturing equipment,
facility and utilities at the Contract Manufacturing (CMO) site.
Equipment may include major processing equipment such as
bioreactors, tangential flow filtration, chromatography, filling
equipment, support systems such as incubators, freezers biosafety
cabinets, offline benchtop instruments or facility/utility
systems.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
- Ensuring new equipment is appropriately designed/qualified and
existing processes runs in a compliant manner through equipment
lifecycle. To include:
- Investigating any equipment or process deviations.
- Developing corrective actions to prevent reoccurrences.
- Appropriate change management for any changes to qualified
- Owns and manages changes to the process equipment to maintain
equipment in a validated state.
- Problem solve any technically related issues impacting
- Develop and implement equipment reliability and maintenance
strategies that are compliant, effective and cost appropriate.
- Routinely monitor equipment performance.
- Develops project objectives working with user requirement and
- Determines project specifications and appropriate technology's
to be implemented.
- Establish equipment specifications in standard documentation -
User Requirements (URS), Functional Specification (FS) and Detail
Design Specifications (DDS).
- Support investigation non-conformances associates with
equipment, facility or utility systems.
- Participate in all FDA and internal audits of the manufacturing
facilities and process equipment and respond to any observations
- Responsible for maintaining quality standards to meet GMP
requirements, CFR's and internal company policies with respect to
- Represent process engineering and validation in any technology
- Responsible for either leading or providing SME support on
capital related projects. Qualifications
- Minimum B.S. degree in Chemical, Electrical or Mechanical
Engineering, or related technical field, or 4 years of equivalent
work experience in pharmaceutical or biopharmaceutical based GMP
- Experience in the development, automation, and manufacture of
gene therapy products, medical devices, instruments, or
- In-depth knowledge of FDA regulations and GMP systems and
experience providing engineering support in a highly regulated or
pharmaceutical / biotech facility.
- 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.
- Travel as required to other internal sites, vendors, and CMOs
as required (-75%).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.
Keywords: AveXis Inc., Durham , Process Engineer - CMO Partnerships, Engineering , Durham, North Carolina
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