MSAT Process Engineer


Houston
Permanent
Negotiable
Engineering
PR/535873_1742583790
MSAT Process Engineer

Job Summary:

The MSAT (Manufacturing Science & Technology) Process Engineer will play a pivotal role in supporting and optimizing the pharmaceutical manufacturing processes. This position will involve process improvements, troubleshooting, scale-up activities, and ensuring that all manufacturing activities comply with Good Manufacturing Practices (GMP). The MSAT Process Engineer will work closely with cross-functional teams to ensure the successful transfer, scaling, and continuous improvement of processes for commercial and clinical products.


Key Responsibilities:

  • Process Optimization: Lead efforts to improve the efficiency, quality, and scalability of manufacturing processes. Identify opportunities for continuous process improvement and cost reduction.

  • Technical Support: Provide hands-on technical support to manufacturing teams during production runs, troubleshooting issues and implementing solutions in real-time.

  • Process Scale-up & Technology Transfer: Collaborate with R&D and manufacturing teams on the scale-up and transfer of new processes from development to commercial production. Ensure smooth transitions while maintaining high-quality standards.

  • Data Analysis: Analyze and interpret process data to identify trends, make informed decisions, and propose improvements. Utilize statistical tools and software to monitor and enhance process performance.

  • Compliance and Documentation: Ensure all activities comply with regulatory requirements, GMP, and internal policies. Document technical procedures, process changes, and troubleshooting efforts to maintain compliance.

  • Collaboration: Work closely with other departments, including Quality Control (QC), Quality Assurance (QA), and Manufacturing, to address technical issues, optimize workflows, and ensure process robustness.

  • Training and Development: Mentor junior engineers and manufacturing personnel on process knowledge, troubleshooting, and best practices. Provide training to enhance technical expertise across the team.


Qualifications:

  • Education: Bachelor of Science in Chemical Engineering, Chemistry, Pharmaceutics, Pharmaceutical Science, or another related field.

  • Experience:

    • Minimum of 5 years of experience in a pharmaceutical or biotechnology manufacturing environment, with a focus on process development, optimization, and troubleshooting.
    • Experience in MSAT or a similar technical field is highly desirable.
  • Technical Skills:

    • Strong knowledge of pharmaceutical manufacturing processes (e.g., biologics, sterile manufacturing, or small molecule production).
    • Familiarity with process control systems, statistical process control (SPC), and process monitoring tools.
    • Understanding of GMP regulations and industry standards.
    • Proficiency in data analysis tools and software (e.g., JMP, Minitab, Excel).
  • Soft Skills:

    • Excellent problem-solving and troubleshooting abilities.
    • Strong communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.
    • Ability to manage multiple tasks and priorities in a fast-paced environment.

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