Bio Process Engineer

We are seeking a motivated Bio Process Engineer to support biopharmaceutical manufacturing operations in a GMP-regulated environment. This is an excellent opportunity for early-career professionals to gain broad exposure to biologics manufacturing, process engineering, technology transfer, process validation, and continuous improvement initiatives. The ideal candidate will have experience supporting upstream and/or downstream manufacturing processes and possess strong analytical and problem-solving skills.

Responsibilities

• Support commercial biopharmaceutical manufacturing processes in a GMP environment.
• Assist with upstream and downstream operations, including cell culture, chromatography, filtration, and purification processes.
• Monitor process performance through data analysis, process trending, and manufacturing metrics review.
• Support technology transfer activities from development to manufacturing.
• Participate in process characterization, process validation, and continuous improvement projects.
• Collaborate with Manufacturing, Quality, Validation, and Technical Operations teams to resolve process-related issues.
• Assist in investigations related to deviations, CAPAs, change controls, and non-conformance events.
• Prepare and maintain technical documentation, reports, protocols, and manufacturing records.
• Support implementation of process analytics, data visualization tools, and digital workflow improvements.
• Provide technical support to manufacturing operations and assist with troubleshooting activities.
• Work with internal stakeholders and external manufacturing partners to support process execution and project objectives.
• Ensure compliance with GMP, quality, and safety requirements.

Required Qualifications

• Bachelor's degree in Chemical Engineering, Biotechnology, Bioengineering, Biochemistry, or a related Life Sciences discipline with 2–4 years of relevant industry experience; OR
• Master's degree in a related field with 1–2 years of relevant biopharmaceutical industry experience.
• Experience in biopharmaceutical manufacturing, process engineering, or process development.
• Familiarity with upstream and/or downstream bioprocess operations.
• Knowledge of GMP manufacturing environments and documentation practices.
• Strong Microsoft Excel and data analysis skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

• Experience with technology transfer, process characterization, or process validation activities.
• Knowledge of quality systems including deviations, CAPAs, investigations, and change controls.
• Experience with biologics manufacturing processes, including mammalian cell culture and/or microbial systems.
• Exposure to CDMO or external manufacturing partnerships.
• Familiarity with process analytics, data visualization tools, or digital workflow platforms.