Process Engineer

Summary

Join Syner-G BioPharma Group and Sequoia Biotech Consulting, a leading life sciences consultancy, as a Process Engineer. You will assist with various aspects of process engineering, from design and development to commissioning and qualification of equipment and systems. This role requires 4-7 years of relevant experience in a cGMP manufacturing environment within an FDA-regulated company. You will provide technical support, lead projects, and ensure compliance with regulations. The company offers a competitive salary, robust benefits, flexible work arrangements, and opportunities for career development. Syner-G BioPharma Group was recently recognized as a Best Place to Work, highlighting its commitment to employee well-being and growth.

Requirements

• 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
• 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
• Experience with Process Engineering, Manufacturing Engineering, MSAT, Commissioning, CQV, and Tech Transfer
• Experience with Fillers, Wave Bioreactor, Cell Processing Systems, Scales, Pumps, Welder/Sealers, and Flow Cytometers
• 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

• 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

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”