Process Engineer

Summary

Join Sequoia Biotech Consulting, a leading life sciences consultancy, as a Process Engineer. This role focuses on drug substance or product manufacturing, particularly large molecule biologics. You will author, update, and review SOPs and technical documentation, work with manufacturing batch records, and support manufacturing operations. The position requires 5-7 years of relevant experience, a Bachelor's degree in a related field, and strong communication and problem-solving skills. Sequoia offers a competitive salary, robust benefits, flexible work arrangements, and career development opportunities.

Requirements

• Bachelor’s degree in Engineering, Bio/Pharma Science, or related technical field of study
• 5-7 years of experience in drug substance manufacturing or drug product manufacturing, with a preference for large molecule, biologics drug substance
• Extensive experience with authoring, updating, and reviewing SOPs and technical documentation related to manufacturing operations
• Experience working with manufacturing batch records and associated documentation
• Experience in a manufacturing support role such as MSAT, MS&T, Manufacturing Services, etc
• Understanding of FDA regulations and GMP practices
• 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

Responsibilities

• Author, update, and review SOPs and technical documentation related to manufacturing operations
• Work with manufacturing batch records and associated documentation
• Provide support in a manufacturing support role such as MSAT, MS&T, Manufacturing Services, etc
• Ensure compliance with FDA regulations and GMP practices
• Collaborate on fast-paced, matrix, cross-functional team projects with defined timelines and deliverables
• Assist in the development and implementation of manufacturing processes and procedures
• 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
• 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

Preferred Qualifications

• Any exposure to MES (Manufacturing Execution Systems), electronic batch records is a plus but not required
• Experience working on fast-paced, matrix, cross-functional team projects with defined timelines and deliverables

Benefits

• Market competitive base salary and annual incentive plan
• Robust benefit offerings
• Ongoing recognition and career development opportunities
• Generous flexible paid time off program
• Company-paid holidays
• Flexible working hours
• Fully remote work options for most positions and the ability to work “almost anywhere”