Process Engineer (Utilities focus)

Location
Longmont, CO, US
Posted
Sep 16, 2020
Ref
5411
Required Education
Associate Degree
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

With cutting-edge technology, we are making progress in the treatment of rare and life-threatening neurological genetic diseases. Our initial gene therapy for spinal muscular atrophy (SMA) has been approved in the U.S., Japan, EU and Brazil.

The Process Engineer is responsible for providing engineering, validation and maintenance support to the process manufacturing equipment, facility and utilities at the manufacturing 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.

Responsibilities
  • Develop an understanding of current and future processes and translate these into the facility and equipment requirements at the manufacturing site.
  • Ensure 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 recurrences.
  • Appropriate change management for any changes to qualified systems.
  • Design review for protection and controls including panel arrangements, one lines/single lines, three lines, AC schematics, equipment wiring and relay panel wiring
  • Owns and manages changes to the process equipment to maintain equipment in a validated state.
  • Problem solve any technically related issues impacting production.
  • 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 business plans.
  • Determines project specifications and appropriate technologies 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 received.
  • Responsible for maintaining quality standards to meet GMP requirements, CFRs and internal company policies with respect to equipment systems.
  • Represent process engineering and validation in any technology transfer activities.
  • Responsible for either leading or providing SME support on capital related projects.
  • Other related duties as assigned.

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 manufacturing operations.
  • Advanced Experience with electrical systems, calculations and principles
  • Extensive understanding of applicable electrical codes
  • 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 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.

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.

Novartis Gene Therapies 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.

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