Process Engineer, III/Senior

Novartis AG-posted 2 months ago
Full-time • Mid Level
Onsite • Durham, NC
5,001-10,000 employees
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Are you ready to shape the future of pharmaceutical manufacturing? As a Process Engineer, Level III/Senior, you'll play a pivotal role in ensuring equipment reliability and compliance across its lifecycle. From leading investigations and audits to mentoring engineers and driving global initiatives, your expertise will directly influence operational excellence and innovation. Join us in making a meaningful impact-where your engineering insight fuels better outcomes for patients worldwide.

  • Ensures new equipment is appropriately designed/qualified and existing processes run in a compliant manner through equipment life cycle. Help define and optimize equipment qualification strategy.
  • Owns and manages changes to the process equipment to maintain equipment in a validated state. Support global initiatives ensuring consistency across manufacturing sites.
  • Investigates any equipment or process deviations and developing corrective actions to prevent re-occurrences. Able to provide industry-wide expertise for complex equipment and process investigations.
  • Participates in all FDA and internal audits of the manufacturing facilities and process equipment as SME and responds to any observations received.
  • Develops and implements equipment reliability and maintenance strategies that are compliant, effective and cost appropriate.
  • Applies knowledge of engineering principles and best practices to ensure robust solutions.
  • Provides mentorship to other process engineers.
  • Leads small internal teams to help optimize engineering systems and processes.
  • Independently lead or provide SME support on capital related projects.
  • Establishes equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS).
  • B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 5 years' work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (9 years) 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.
  • Diverse experience in the development, automation, and manufacture of gene therapy products, medical devices, instruments, or biotechnology.
  • B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 8 years' work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (12 years) 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.
  • Diverse experience in the development, automation, and manufacture of gene therapy products, medical devices, instruments, or biotechnology.
  • In-depth knowledge of FDA regulations and GMP systems and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility.
  • Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning.
  • Demonstrates skill in developing contingency plans and solving complex problems under pressure.
  • 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.
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