Process Engineer – 100% Travel

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October 22

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Syner-G BioPharma Group

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Syner-G BioPharma Group is the world's leading provider of chemistry, manufacturing and controls (CMC), regulatory affairs, and medical writing solutions for the biopharma sector. They offer comprehensive services that navigate clients through the complexities of pharmaceutical development, regulatory submissions, and quality compliance, ensuring high-quality outcomes. With a multidisciplinary team, Syner-G integrates science, engineering, and regulatory expertise to support drug development from pre-IND to post-approval phases, enabling timely submissions and patient safety adherence.

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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.

🎯 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.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options