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Process Engineer

3 months ago

Raleigh, United States Sequoia Biotech Consulting Full time
Company Description

Sequoia Biotech Consulting is a leading life sciences consultancy, dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale, and quality of life-saving innovations. Our multidisciplinary team of scientists, engineers, quality experts, and business professionals specializes in optimizing product development, technology transfer, and commercial manufacturing. Additionally, we equip our partners with the tools, knowledge, and expertise to streamline operations, enhance quality, and ensure compliance.

For more information, visit www.sequoiabiotech.com/.

Sequoia is seeking an experienced Process Engineer to assist with, but not limited to the following; process engineering, process development, materials & engineering sciences, technology transfer, facilities/ utilities/ technical services and manufacturing processes.

Responsibilities
  • Assist with the requirements specifications, design, functional requirements, development, commission and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit.
  • Assist with the risk assessments, feasibility reviews, risk mitigations and testing of process materials to ensure compliance with manufacturing requirements.
  • Assist with the requirements specifications, design & development of process parameters and the commission/ validation of manufacturing processes for compliance with quality and regulatory requirements
  • Provide technical support for the product/ process lifecycle and related activities
  • Support client requirements to lead or help process or engineering projects at vendors or other third-party contract companies, as needed.
  • Provide support for improvement projects regarding processes and systems.
  • Support or provide risk assessment and mitigation activities for process development, manufacturing, and testing as applicable
  • Provide technical support of scale-up activities from development to manufacturing, including but not limited to; Technology Transfers, Facilities improvements (ie. utilities/ equipment integration, etc.)
  • Analyze and recommend improved technology to increase quality and efficiency
  • Provide technical analysis and support of new or improvements to process systems
  • Facilitate and schedule meetings with subject matter experts across an organization
  • Ensure compliance with cGMP, regulatory, and industry standards
Qualifications
  • Bachelor's degree in Engineering, Bio/Pharma Science or related technical field of study
  • 2 - 10+ years of related engineering and/or technical experiences required
  • Experience with cGMP Manufacturing within a FDA regulated manufacturing company
  • Knowledge of cGxP Quality Systems within a FDA regulated manufacturing company
  • Knowledge of FDA regulations and guidances or applicable regulatory standards and practices
  • Proficient with MS Office suite, MS Project, Visio, and related electronic formats required to perform the respective job at a client.
  • Knowledge of laboratory and manufacturing systems such as LIMS, MES, etc.
  • Excellent computer, verbal, and written communication skills
  • Innovative problem-solving skills and integrated view of business/ scientific issues
  • Accountable and Responsible individual to perform as intended for clients.
  • Willingness to travel to various clients when needed, with acceptable limitations during noted health pandemics or related constraints.


Additional Information

Sequoia offers a comprehensive suite of benefits including, medical, dental, vision coverage, 401K, and company paid life-insurance.

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