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Manufacturing Process Specialist

2 months ago

Houston, Texas, United States DSJ Global Full time

Key Responsibilities

  • Enhances production methodologies to create sterile finished products, focusing on both upstream and downstream processes, particularly in isolation technologies.
  • Implements process enhancements aimed at improving product quality, yield, and operational efficiency.
  • Conducts risk evaluations of processes and executes Corrective Actions / Preventative Actions (CAPAs) to mitigate risks.
  • Works collaboratively with cross-functional teams, including production and quality assurance, to facilitate product manufacturing activities.
  • Leads investigations into process deviations, identifies underlying causes, and applies corrective and preventive measures.
  • Engages in technology transfer initiatives to ensure seamless transition of processes from development to production.
  • Creates and maintains process documentation such as Standard Operating Procedures (SOPs), Work Instructions, and other relevant cGMP documents.
  • Offers technical guidance, oversight, and training to production staff to ensure effective execution of manufacturing processes.
  • Contributes to the design and validation of manufacturing equipment, new product development, and overall quality initiatives.
  • Optimizes sterilization, depyrogenation, cleaning, and conversion processes while addressing technical challenges and regulatory requirements.
  • Conducts studies and risk assessments to identify potential hazards and develop mitigation strategies.
  • Utilizes collaborative efforts across research and development, quality assurance, and manufacturing to integrate sterilization processes into product development and production.
  • Troubleshoots sterilization equipment and processes to ensure efficient operation and minimal downtime.
  • Analyzes process data to identify trends, enhance performance, and promote continuous improvement initiatives.
  • Brings technical expertise to support compliance with industry standards and regulatory requirements, including FDA, ISO, and cGMP.
  • Participates in validation activities, including protocols for installation qualification, operational qualification, and performance qualification, to ensure the reliability of sterilization processes.
  • Manages document control, creation, and issuance to ensure SOPs and other guidance documents are accurate and clear for Sterile Manufacturing Operators.
  • Generates reports, graphs, and presentations to provide technical support to Executive Leadership and Senior Leadership Teams.

Qualifications

Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutics, Pharmaceutical Science, or a related discipline.

  • Proficient in Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook.
  • Strong understanding of aseptic processing requirements and cGMP for sterile manufacturing.
  • In-depth knowledge of chemical processes, materials science, thermodynamics, and fluid mechanics.
  • Familiarity with FDA regulations, cGMP, ISO standards, and drug product requirements.
  • Understanding of quality control analysis and associated process parameters for analytical and in-process testing.
  • Knowledge of International Council for Harmonization (ICH) stability requirements for pharmaceuticals.
  • Ability to develop and review operational standards and procedures.
  • Strong communication skills to convey technical issues to both technical and non-technical audiences.

Experience

  • A minimum of five years of experience as an engineer, particularly in managing drug product conversion in an aseptic environment.
  • A Master's degree with 2-3 years of direct process engineering experience may be considered.
  • Experience with liquid dosage form processes, including mixing, weighing, fluid flow, filtration, filling, sterilization, and lyophilization.
  • Experience with Failure Mode and Effects Analysis (FMEA), engineering support, CAPA, and new product development.