Process Engineer

Process Engineer

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 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.
• 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.

Preferred Qualifications

No preferred qualifications provided.