Process Engineer I

Novartis • Durham, NC

6d

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 position also involves executing administrative preventative maintenance activities, facilitating equipment maintenance, calibration, and qualification with external vendors, and investigating equipment or process deviations to develop corrective actions. The Process Engineer will participate in FDA and internal audits as a Subject Matter Expert (SME) and monitor equipment performance in compliance with site reliability and maintenance strategies. They will apply engineering principles to ensure robust solutions, help evaluate new technologies, and perform 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 4 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

• 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.

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