Manufacturing Process Specialist

2 weeks ago


Raleigh, North Carolina, United States Sequoia Biotech Consulting Full time
Company Overview

Sequoia Biotech Consulting stands at the forefront of life sciences consulting, committed to assisting organizations in navigating intricate challenges while expediting the development, scalability, and quality of critical innovations that save lives. Our diverse team comprises scientists, engineers, quality assurance professionals, and business strategists, all focused on enhancing product development, facilitating technology transfer, and optimizing commercial manufacturing processes. We empower our partners with the necessary tools, insights, and expertise to refine operations, boost quality, and maintain compliance.

Position Summary

Sequoia is in search of a skilled Manufacturing Process Specialist to contribute to various aspects including process engineering, development, materials science, technology transfer, and manufacturing operations.

Key Responsibilities
  • Assist in the creation of requirement specifications, design, functional requirements, and the development, commissioning, and qualification of process equipment or systems to meet manufacturing needs and facility compatibility.
  • Support risk assessments, feasibility evaluations, risk mitigation strategies, and testing of process materials to ensure adherence to manufacturing standards.
  • Contribute to the specification, design, and development of process parameters, along with the commissioning and validation of manufacturing processes to comply with quality and regulatory standards.
  • Provide technical assistance throughout the product and process lifecycle and associated activities.
  • Support client needs by leading or assisting with engineering projects at vendors or third-party contractors as required.
  • Offer support for process and system improvement initiatives.
  • Engage in risk assessment and mitigation efforts related to process development, manufacturing, and testing as applicable.
  • Facilitate technical support for scale-up activities transitioning from development to manufacturing, including Technology Transfers and facility enhancements (e.g., utilities and equipment integration).
  • Analyze and propose advanced technologies to enhance quality and operational efficiency.
  • Conduct technical evaluations and provide support for new or improved process systems.
  • Organize and lead meetings with subject matter experts across the organization.
  • Ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and industry standards.
Qualifications
  • Bachelor's degree in Engineering, Bio/Pharma Science, or a related technical discipline.
  • Several years of relevant engineering and/or technical experience.
  • Experience in cGMP manufacturing within a regulated environment.
  • Familiarity with cGxP Quality Systems in a regulated manufacturing setting.
  • Understanding of FDA regulations and guidelines or applicable regulatory standards and practices.
  • Proficient in MS Office Suite, MS Project, Visio, and other electronic formats necessary for client tasks.
  • Knowledge of laboratory and manufacturing systems such as LIMS and MES.
  • Exceptional computer, verbal, and written communication skills.
  • Innovative problem-solving abilities with a comprehensive view of business and scientific issues.
  • Accountable and responsible approach to fulfilling client expectations.
  • Willingness to travel to various client locations as necessary, adhering to health guidelines and restrictions.
Additional Information

Sequoia provides a comprehensive benefits package, including medical, dental, and vision coverage, a 401K plan, and company-paid life insurance.

Sequoia is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, and veteran status.

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