Principal Process Engineer

Sequoia is seeking an experienced Principal 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
• 18+ 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.