Aseptic Process Optimization Engineer

2 weeks ago

Houston, Texas, United States DSJ Global Full time

Key Responsibilities

  • Enhances production methodologies to yield sterile final products, concentrating on both upstream and downstream processes, particularly in isolation technologies.
  • Develops and executes process enhancements aimed at improving product quality, efficiency, and yield.
  • Conducts risk evaluations of processes and implements Corrective Actions / Preventative Actions (CAPAs) to mitigate risks.
  • Works collaboratively with diverse teams, including manufacturing and quality assurance, to facilitate product commercialization.
  • Leads inquiries into process deviations, identifies underlying causes, and enacts corrective and preventive measures.
  • Engages in technology transfer initiatives to guarantee seamless transition of processes from development to production.
  • Creates process documentation such as Standard Operating Procedures (SOPs), Work Instructions, and other essential Current Good Manufacturing Practice (cGMP) documents.
  • Offers technical guidance, oversight, and training to production staff to ensure effective execution of manufacturing protocols.
  • Contributes to the design and validation of manufacturing apparatus, new product development, and overall Right First-Time strategies.
  • Refines sterilization, depyrogenation, cleaning, and conversion processes in light of technical challenges and regulatory requirements.
  • Conducts studies and risk assessments to pinpoint potential hazards and devise mitigation strategies.
  • Utilizes interdisciplinary collaboration, including research and development, quality assurance, and manufacturing, to incorporate sterilization processes into product development and production.
  • Troubleshoots sterilization equipment and processes to ensure optimal operation and minimal downtime.
  • Analyzes process data to discern trends, enhance performance, and drive continuous improvement efforts.
  • Brings technical acumen to ensure adherence to industry standards and regulatory guidelines, including those set by the Food and Drug Administration (FDA), International Organization for Standardization (ISO), and cGMP.
  • Participates in validation activities, including protocols for installation qualification, operational qualification, and performance qualification, to ensure the reliability and efficacy of sterilization processes.
  • Manages document control, creation, and distribution to ensure SOPs and other guidance documents are accurate, clear, and concise, aiding Sterile Manufacturing Operators in their tasks.
  • Generates reports, graphs, and presentations, providing technical support to Executive Leadership and Senior Leadership Teams.

Qualifications

A Bachelor of Science degree in Chemical Engineering, Chemistry, Pharmaceutics, Pharmaceutical Science, or a related discipline.

  • Proficient in Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook.
  • Solid understanding of aseptic processing requirements and cGMP for aseptic manufacturing, filtration, and filling.
  • Comprehensive knowledge of chemical processes, materials science, thermodynamics, and fluid mechanics.
  • Familiarity with FDA regulations, cGMP, ISO standards, and drug products.
  • Understanding of quality control analysis and process parameters related to analytical testing results and in-process testing is advantageous.
  • Knowledge of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human stability requirements.
  • Ability to develop and review operational standards and procedures.
  • Strong communication skills to convey technical issues effectively to both technical and non-technical audiences.

Experience and Qualifications

  • A minimum of five years of experience as an engineer, particularly in managing drug product conversion in an aseptic environment is highly desirable.
  • A Master of Science degree with 2-3 years of direct process engineering experience may be considered.
  • Experience with liquid (injectable) dosage form mixing, weighing, fluid flow, filtration & filling, sterilization, lyophilization, and other fundamentals of liquid production is a plus.
  • Experience with Failure Mode and Effects Analysis, engineering support, CAPA, and new product development/introduction.

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