Process Engineer - Sequoia Biotech Consulting

What you will be doing:

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

Is this job for you?

• Assist with the requirements specifications, design, functional requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit.
• Lead start-up activities, including commissioning and qualification of facilities, utilities, and equipment (FUE).
• Assist with 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 commissioning/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 for scale-up activities from development to manufacturing, including but not limited to technology transfers and facilities improvements (e.g., utilities/equipment integration).
• Analyze and recommend improved technology to increase quality and efficiency.
• Provide technical analysis and support for new or improved process systems.
• Facilitate and schedule meetings with subject matter experts across the organization.
• Ensure compliance with cGMP, regulatory, and industry standards.

Who you are:

• Bachelor's degree in Engineering, Bio/Pharma Science, or a related technical field of study.
• 4-7 years of related engineering and/or technical experience required.
• Experience with cGMP Manufacturing within an FDA-regulated manufacturing company.
• Knowledge of cGxP Quality Systems within an FDA-regulated manufacturing company.
• Knowledge of FDA regulations and guidance 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 an 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.

We provide a comprehensive Total Rewards Program not limited to: 

• Excellent healthcare options: Medical, vision, prescription & dental 

• Family Focus & Balance: Parental leave, flexible time-off and Employee Assistance Program 

• Financial Security: 401(k) with employer matching 

• Tuition Reimbursement: Continuing education for every season of your career 

• Employee Recognition Programs 

Compensation 

Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $106,991.88 yearly in our lowest geographic market up to $152,382.37 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.