Process Engineer II

Location
Durham, NC
Posted
Jan 13, 2022
Ref
2021-6425
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

Imagine… 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

 

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

Responsibilities

  • Ensuring new equipment is appropriately designed/qualified and existing processes runs in a compliant manner through equipment lifecycle.
  • Owns and manages changes to the process equipment to maintain equipment in a validated state.
  • Potentially take on a global role in ensuring consistency across manufacturing sites.
  • Investigating any equipment or process deviations and developing corrective actions to prevent reoccurrences.
  • Participate in all FDA and internal audits of the manufacturing facilities and process equipment as
  • SME and respond to any observations received. 
  • Actively monitor equipment performance in compliance with site reliability and maintenance strategies. Applies knowledge of engineering principles and best practices to ensure robust solutions.
  • Provide mentor-ship to other process engineers.
  • Assist to provide SME support on capital related projects. Establish equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS).
  • Help evaluate new technologies and equipment platforms for manufacturing.
  • Providing engineering, validation and maintenance support to the process manufacturing equipment, facility and utilities at a site. Equipment may include major processing equipment such as bioreactors, tangential flow filtration, chromatography, filling equipment, support systems such as incubators, freezers bio-safety cabinets, offline bench-top instruments or facility/utility systems. 
  • Assists with the translation of current and future processes into the facility and utility equipment requirements at a manufacturing site.
  • Other related job duties as assigned.

Qualifications

  • B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 2 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or 6 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
  • Excellent oral and written communication skills. Strong technical writing ability required.
  • Working in a team environment, with excellent communication and organizational skills.
  • Experience in the development, automation, and manufacture of gene therapy products, medical devices, instruments, or biotechnology. 
  • Strong foundation FDA regulations and GMP systems and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility.
  • Developing professional expertise, applies company policies and procedures to resolve a variety of issues. 
  • Ability to work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
  • Exercises judgment within defined procedures and practices to determine appropriate action. 
  • Builds productive internal/external working relationships.

 

The level of this position will be based on the final candidate's qualifications. 

 


Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.


We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!  Imagine what you could do here at Novartis!


Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

 

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.

 

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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