Process Engineer I

U473 (FCRS = US473) Novartis Gene Therapies; North Carolina; On-site; USD 41,000 - 76,000; Full time

Job summary

Novartis Gene Therapies in North Carolina seeks a Process Engineer I or II to provide engineering, validation, and maintenance support for process manufacturing equipment, facilities, and utilities at the site. You will manage equipment lifecycle, coordinate with vendors, and assist in audits and investigations.

The role requires a BS in chemical/electrical/mechanical engineering (or related field) with experience in regulated biopharma environments, strong communication and problem-solving

Qualifications

• B.S. degree in Chemical, electrical or mechanical engineering or related technical field.
• Experience in GMP biopharmaceutical manufacturing is preferred.
• Excellent written and verbal communication skills.

Responsibilities

• Ensure new equipment is designed/qualified and maintained in a compliant state throughout lifecycle.
• Execute administrative preventive maintenance activities as equipment owner.
• Facilitate equipment maintenance, calibration, and qualification with external vendors.
• Provide engineering, validation and maintenance support to process manufacturing, facilities and utilities at the site.
• Equipment will include bench-top instruments, biosafety cabinets, incubators and freezers; back-up for major processing equipment.
• Own and manage small to medium changes to process equipment to maintain a validated state.
• Investigate equipment or process deviations and develop corrective actions to prevent recurrences.
• Participate in FDA and internal audits as SME and respond to observations.
• Monitor equipment performance in line with site reliability and maintenance strategies.
• Apply engineering principles to ensure robust solutions and evaluate new technologies.

Skills

Communication skills

Technical writing

Team player

FDA regulations awareness

Education

B.S. in Chemical, Electrical or Mechanical Engineering

Job description

Job Description Summary

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.

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 $ 41,100 and $76,300 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically.

Novartis may change the published salary range based on company and market 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.

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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Skills Desired Operational Excellence

Salary Range $41,100.00 - $76,300.00

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.