Process Engineer I

Novartis Farmacéutica; Durham, Northern (NC, KY); Hybrid; USD 41,000 - 76,000; Full time

Job summary

Novartis Gene Therapies in Durham, NC is seeking a Process Engineer I or II to provide engineering, validation and maintenance support for process manufacturing equipment, facilities and utilities at the site. The role covers equipment qualification, calibration, deviations, audits, and collaboration with vendors, with growth to more complex processing equipment such as bioreactors and chromatography.

Candidates should have a BS in Chemical, Electrical or Mechanical Engineering and strong

Qualifications

• BS in Chemical, Electrical or Mechanical Engineering or related field.
• Experience: Engineer I <2 years; Engineer II >2 years in pharmaceutical GMP manufacturing operations.
• Excellent oral and written communication skills.
• Strong teamwork and organizational abilities.
• Awareness of FDA regulations and GMP systems; experience in regulated pharma/biotech facilities.

Responsibilities

• Ensures new equipment is designed/qualified and existing equipment maintained in a compliant manner.
• Performs preventative maintenance activities as equipment owner.
• Coordinates maintenance, calibration and qualification with external vendors.
• Provides engineering, validation and maintenance support to process manufacturing equipment, facilities and utilities.
• Owns and manages small-to-medium changes to process equipment to maintain validated state.
• Investigates deviations and implements corrective actions.
• Participates in FDA/internal audits as SME and responds to observations.
• Monitors equipment performance in line with site reliability strategies.
• Evaluates new technologies and equipment platforms for manufacturing.
• Other related duties as assigned.

Skills

Communication

Technical writing

Teamwork

FDA/GMP familiarity

Education

B.S. in Chemical Engineering

B.S. in Electrical Engineering

B.S. in Mechanical Engineering

Job description

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.

About the Role

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 $41,100 and $76,300per year.The 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 factors.Your compensation will include a performance-based cash incentive and, depending on the level of therole, eligibility to be considered for annual equity awards.US-based eligible employees will receive a comprehensive benefits package that includes health,lifeanddisability 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 days,holidaysand other leaves.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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.

Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [emailprotected] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Division Operations

Business Unit Production / Manufacturing

Location USA

State North Carolina

Site Durham

Company / Legal Entity U473 (FCRS = US473) Novartis Gene Therapies