Process Engineer, SQA Services

Process Engineer

Compounding Processing Engineer is a critical technical role for the company and supports development, scale up and manufacturing of cosmetic and OTC batching. The incumbent will support our growth and have a strong focus on safety, quality and compliance. Responsible for all processes related to raw materials – incoming raw testing, storing, pre-weighing, compounding and filling as well as oversee different areas ensuring all SOPs and GMPs are followed and product meets general QC requirements.

Responsibilities:

  • Works in a specific area of operation (hot fill, high viscosity products, lip balm filling, powders or solids as examples).
  • Conducts analysis of current processes and determine/recommend optimal improvements.
  • Collects, compiles, and analyzes process data by capturing critical processing parameters and operating information for more data-based decision making, trending, and analysis
  • Creates short and long-term improvements that may be achieved through major capital investments or a series of smaller improvements or expansion projects.
  • Responsible for all products that come from R&D for scale-up.
  • Converts lab processes into fully commercial products, working closely with the R&D chemist to understand critical processing steps and phases, sensitivities to shear, temperature, and other conditions.
  • Supports Process Validation and Equipment Qualification activities
  • Writes manufacturing instructions, supervises pilot and 1st shift production, stabling final specifications and training manufacturing personnel.

Requirements:

  • Demonstrated comprehensive understanding of upstream processes such as pre-weight/cleaning and their impact.
  • Downstream processes and how to optimize the satisfaction of internal customers such as filling should be completely understood as well.
  • Successfully transfer newly developed formulations to manufacturing by converting lab processes and observations into practical, appropriate and scale-able production or processes.
  • Continuously improves previously release formulation processes that are or become problematic if batches are unable to be fully completed using the manufacturing instructions, require significant adjustments to get close to or do not have documentation indications specific equipment requirements.
  • Investigation and problem-solving tools are utilized to determine root cause and effective corrective actions.
  • BS Degree required, chemical science or chemical engineering strongly preferred
  • 3-7 years of compounding and filling process improvement experience in cosmetic and or pharmaceutical industries.
  • Technically strong in batch manufacturing operations, related batching equipment, and problem solving
  • Demonstrated ability to train and work with manufacturing personnel.
  • Capable of partnering with R&D, maintenance and quality personnel
  • Trained in cGMP requirements, including batch documentation and sanitization

If interested in this position, please contact Tami Parker at TParker@sqaservices.com or call 310-802-4415.