Process Engineer III

Band

Level 3

 

Job Description Summary

#LI-Onsite
#Engineering #ProcessEngineering

Location: Durham, NC

This role is based in Durham, NC. Novartis is unable to offer relocation support: please only apply if accessible.

As a Process Engineer III, you’ll ensure new laboratory equipment is appropriately designed and qualified and that lab operations run in a compliant manner throughout the equipment lifecycle. You’ll help define and optimize equipment qualification strategy, own changes needed to maintain equipment in a validated state and lead complex equipment investigations and CAPA’s. You’ll partner closely with Laboratory Operations and Manufacturing Sciences on new assay/product introductions and lab fit evaluations, provide mentorship to other engineers, and contribute to strategic equipment and technology roadmaps that keep the lab ready for what’s next.

 

Job Description

Key Responsibilities:

• Provide engineering, validation, and maintenance support to laboratory equipment, lab support systems, and utilities at the site; equipment may include chromatography systems (HPLC), capillary electrophoresis (CE) instruments, incubators, freezers, biosafety cabinets, centrifuges, balances, and other offline bench-top instruments and lab utility systems.
• Ensure new equipment is appropriately designed and qualified and that existing processes run in a compliant manner through the equipment lifecycle; help define and optimize the equipment qualification strategy.
• Own and manage changes to laboratory equipment and lab utility/support systems to maintain equipment in a validated state; where applicable, contribute to cross-site consistency of engineering/validation approaches.
• Investigate laboratory equipment deviations and instrument performance issues and develop corrective actions to prevent recurrence; provide technical expertise for complex equipment investigations.
• Participate in FDA and internal audits as a subject matter expert (SME) for laboratory areas and laboratory equipment; support inspection readiness and respond to observations.
• Develop and implement equipment reliability and maintenance strategies that are compliant, effective, and cost appropriate.
• Establish equipment specifications in standard documentation (e.g., User Requirements, Functional Specifications, and Detailed Design Specifications) and author/review associated protocols, reports, and SOPs.
• Independently lead or provide SME support on capital projects, including scope definition, vendor engagement, installation/commissioning, qualification, and handover to Operations.
• Work closely with Laboratory Operations and Manufacturing Sciences to evaluate new assay/product introductions and lab fit/readiness; translate current and future testing needs into laboratory equipment, utilities, and space requirements at the site.
• Apply engineering principles and best practices to ensure robust solutions; provide mentorship to other process engineers; lead small teams to optimize engineering systems and processes; lead evaluation of new technologies/equipment platforms; and help define and advance facility/equipment changes aligned with 5- and 10-year strategic plans.

Essential Requirements:

• B.S. degree in Chemical, Electrical, or Mechanical Engineering (or related technical field) with 5 years of work experience in pharmaceutical or biopharmaceutical GMP manufacturing operations; or equivalent work experience (9 years) in pharmaceutical or biopharmaceutical GMP manufacturing operations.
• Excellent oral and written communication skills; strong technical writing ability required.
• Ability to work effectively in a team environment with strong communication and organizational skills.
• In-depth knowledge of FDA regulations and GMP systems, and experience providing engineering support in a highly regulated pharmaceutical/biotech facility.
• Strong project management skill set with experience in strategic and tactical planning, including long-term project planning.
• Ability to prepare contingency plans and logically work through complex issues in a high-pressure environment; uses professional concepts to solve complex problems in creative and effective ways.
• Demonstrated ability to lead cross-functional teams (including across manufacturing locations) in a fast-paced, dynamic environment; demonstrates good judgment in selecting methods and techniques to obtain solutions and networks with senior internal/external personnel in area of expertise.

Desirable Requirements:

• Diverse experience in the development, automation, and manufacture of gene therapy products, medical devices, instruments, or biotechnol