Manufacturing Process Engineer

2 weeks ago

Chantilly, Virginia, United States Granules Pharmaceuticals Full time

Job Type: Full-time

Description: Under general supervision, evaluates specifications for processing equipment utilized in the creation of solid oral, semi-solid, liquid, and injectable dosage forms.

Provides assistance in project coordination and follow-through, aids in problem resolution, conducts efficiency studies, and identifies opportunities for process enhancements.

This role involves the development of manufacturing processes for pharmaceutical products, updating procedures and specifications, and documenting studies performed along with their outcomes.

Engagement in new product formulation, scale-up process optimization, process validation, and technology transfers is essential. Participation in the timely production of supplies to support clinical and stability programs is also required.

JOB DUTIES & RESPONSIBILITIES:

  • Independently supports formulation activities in early-stage research.
  • Oversees and coordinates development manufacturing events.
  • Operates various processing equipment and analytical instruments during formulation tasks, including Granulators, Dryers, Blenders, Tablet coaters, Fluid Bed coaters, HPLC, pH meters, viscometers, and particle size testing equipment.
  • Conducts Installation Qualification/Operational Qualification (IQ/OQ) for all necessary equipment.
  • Documents and records information such as report sheets and laboratory notebooks in accordance with Standard Operating Procedures.
  • Responsible for the design and development of products and processes used in manufacturing, from small-scale operations to commercial production.
  • Analyzes and interprets protocols and experimental data to establish product and process specifications.
  • Evaluates existing equipment and recommends modifications as needed for process optimization.
  • Communicates test data and findings to management as required.
  • Trains personnel involved in small-scale manufacturing as necessary.
  • Must be able to lift up to 50 pounds.

Requirements:

Minimum Education & Experience:

Bachelor's or Master's degree in engineering or a related field from an accredited institution. A minimum of 2 years of experience in designing products/processes and installing, operating, and troubleshooting equipment in pharmaceutical manufacturing, food, or cosmetic environments, or an equivalent combination of training and experience.

Required Knowledge & Skills:

  • Understanding of Current Good Manufacturing Practices (cGMP), FDA, DEA, and other regulatory requirements.
  • Knowledge of engineering principles applied to manufacturing processes, including mixing, coating, die-cutting, pouching, and filling.
  • Familiarity with pharmaceutical quality control and manufacturing processes.
  • Proficiency in sampling, testing, measuring techniques, and principles of mathematical and statistical computations.
  • Understanding of mechanical and electrical concepts.
  • Proficient in English usage, spelling, grammar, and punctuation.
  • Skilled in personal computer operations and Microsoft applications (CAD, Word, Access, and Excel).
  • Knowledge of statistical process control.

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