Process Engineer III

Novartis • Durham, CA

4d • Onsite

About The Position

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.

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.

Nice To Haves

• Diverse experience in the development, automation, and manufacture of gene therapy products, medical devices, instruments, or biotechnology.
• Demonstrated experience mentoring engineers and leading small teams to standardize practices, optimize engineering systems/processes, and drive continuous improvement.

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees