Systems & Process Engineering

The Process Engineer I or II (depending on experience) is responsible for providing engineering, validation and maintenance support to the process manufacturing equipment, facility and utilities at the site.
Ensuring new equipment is appropriately designed/qualified and existing equipment is maintained in a compliant manner throughout equipment lifecycle.
Executes administrative preventative maintenance activities as equipment owner.
Facilitates equipment maintenance, calibration, and qualification with external vendors.
Provides engineering, validation and maintenance support to the process manufacturing or laboratory equipment, facility and utilities at a site. Equipment will primarily include support systems such as portable assets, bench-top instruments, bio-safety cabinets, incubators, or freezers; provides back-up support for major processing equipment such as bioreactors, tangential flow filtration, chromatography, and filling equipment.
Owns and manages small to medium changes to process equipment to maintain equipment in a validated state.
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 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.
Help evaluate new technologies and equipment platforms for manufacturing.
Process Engineer I:
S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with
~ Process Engineer II:

• S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with
• 2 years relevant work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or 6 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations.

Strong technical writing ability required.
Awareness of FDA regulations and GMP systems or 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.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
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 to perform the essential functions of a position, please send an e-mail to [email protected] or call View phone number on us.fitly.work and let us know the nature of your request and your contact information.