Process Engineer I

Biopharma Careers; North Carolina; On-site; USD 41,000 - 76,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Paid time off

Job summary

Novartis seeks a Process Engineer I or II for its North Carolina site to provide engineering, validation, and maintenance support for process manufacturing equipment, facilities and utilities. The role involves ensuring equipment is designed/qualified, managing maintenance, and coordinating calibration with external vendors.

The candidate should have a B.S. in Chemical, Electrical or Mechanical Engineering with 2 years of GMP pharma experience (or 6 years equivalent) and possess excellent

Qualifications

• B.S. degree in Chemical, Electrical or Mechanical Engineering or related field, with 2 years GMP pharma experience or 6 years equivalent.
• Excellent oral and written communication skills.
• Strong technical writing ability.
• Experience in a regulated pharma/biotech facility and FDA awareness.

Responsibilities

• Ensure new equipment is designed/qualified and existing equipment maintained in a compliant state.
• Perform preventative maintenance activities as equipment owner.
• Coordinate calibration and qualification with external vendors.
• Provide engineering, validation and maintenance support for process equipment and utilities.
• Support equipment such as benchtop instruments, biosafety cabinets, incubators and freezers; assist with major processing equipment.
• Investigate deviations and implement corrective actions to prevent recurrence.
• Participate in FDA and internal audits as SME and respond to observations.
• Monitor equipment performance per site reliability strategies.
• Apply engineering principles to ensure robust solutions and evaluate new technologies for manufacturing.
• Other related duties as assigned.

Skills

Communication skills

Technical writing

Team collaboration

Education

B.S. degree in Chemical, Electrical or 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.

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

• 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.

Benefits

• 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.