Process Engineer I

Novartis • Durham, NC

5d

About The Position

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. This role ensures new equipment is appropriately designed/qualified and existing equipment is maintained in a compliant manner throughout its lifecycle. The engineer will execute administrative preventative maintenance activities as equipment owner and facilitate equipment maintenance, calibration, and qualification with external vendors. They will provide engineering, validation, and maintenance support to process manufacturing or laboratory equipment, facility, and utilities. Equipment support will primarily include systems such as portable assets, bench-top instruments, bio-safety cabinets, incubators, or freezers, with back-up support for major processing equipment like bioreactors, tangential flow filtration, chromatography, and filling equipment. The role involves owning and managing small to medium changes to process equipment to maintain its validated state, investigating equipment or process deviations, and developing corrective actions. Participation in FDA and internal audits as a Subject Matter Expert (SME) and monitoring equipment performance in compliance with site reliability and maintenance strategies are key. The engineer will apply knowledge of engineering principles and best practices to ensure robust solutions and help evaluate new technologies and equipment platforms for manufacturing. Other related job duties may be 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.

Nice To Haves

• Operational Excellence

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.
• 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.

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level