Process Engineer I

Band

Job Description Summary

Job Description

Responsibilities:

• 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.
• Other related job duties as assigned.

Requirements:

• Process Engineer I:
  • B.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 4 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
• Process Engineer II:
  • B.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.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Working in a team environment with excellent communication and organizational skills.
• 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.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Builds productive internal/external working relationships.

The salary for this position is expected to range between $41100 and $76300per final salary offered isdeterminedbased on factors like but not limited to relevant skills andexperience and upon joiningNovartiswill be reviewed periodically. Novartis may change the publishedsalary range based on company and market compensation will include a performance-based cash incentive and depending on the level of therole eligibility to be considered for annual equity -based eligible employees will receive a comprehensive benefits package that includes healthlifeanddisability benefits a 401(k) with company contribution and match and a variety of other benefits. Inaddition employees are eligible for a generous time off package including vacation personal daysholidaysand other leaves.

To learn more about the culture rewards and benefits we offer our people click here.

EEO Statement:

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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

Skills Desired