Process Engineer

2 weeks ago

Essex Junction, United States Autumn Harp Inc. Full time
Job DescriptionJob Description

The Process Equipment Engineer is part of the Research & Development team and is responsible for Process Design, Scale Up, Compounding Equipment knowledge, FMI creation and maintenance, and OTC Validation training required for product development. They will act as a liaison within the scrum team environment and be responsible for product development and scale-up from the lab bench to steady-state production. The Process Engineer must be both knowledgeable and willing to learn OTC and cosmetic validation procedures under the guidance of the Senior Process Engineer to be able to communicate effectively with internal and external customers. The Process Engineer is also responsible for the investigation of out of specification batches working collaboratively with cross function teams to ensuring that all designed processes adhere to the quality, safety, and cleanliness standards of Autumn Harp, as well as supporting the needs of the greater R&D lab team when necessary.

Key Responsibilities

  • Participating member of a Scrum team for new product development
  • Technical expert on all compounding kettles and equipment, with a focus on ownership of the rapid prototyping pilot vessel; including kettle logistics & physical batching/cleaning: scheduling, cleaning, maintenance, and training.
  • Manages the process design and implementation needed for blue sky and market-trend development batches.
  • Responsible for maintaining the health of FMI documents and batching processes in a timely manner through the PCR process. As well as authoring FMI documents for new experiments, pilots and/or productions when needed.
  • Provides technical support and scheduling advice to the compounding department, assisting and providing guidance to Team Leads and Batchers.
  • Develop & write technical OTC batching validation protocols that meet FDA guidelines.
  • Work in partnership with R&D, Regulatory and Quality to complete PCRs (process change requests) for production.
  • Completes investigations in collaboration with the Quality team on out of specification product.
  • Plays a key role working with customers who are on site to make new products, ensuring customer satisfaction.
  • Cross train to fully support the entire pilot team process for R&D, Batching and Filling
    Special projects as assigned for process improvements and R&D lab support (lab batches, stability, product safety, etc.)

Experience and Skills required:

  • 5+ years of related process engineering experience
  • BS in engineering, chemical engineering preferred
  • Direct experience working in a GMP environment
  • Experience working with manufacturing processing equipment
  • Ability to connect with external and internal customers
  • Independent, creative and logical thinker with a problem-solving mindset
  • Excellent written, verbal, computer and math skills
  • Basic understand of chemistry and databases
  • Process excellence in support of continuous improvement

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