Senior Process Engineer, Process Development

Role Summary

Senior Process Engineer, Process Development responsible for supporting development and transfer of processes for IgG Immunotherapy Production, ensuring compliance and operational efficiency within the PD team and cross-functional collaboration.

Responsibilities

• Provide technical support for issues related to the manufacturing process and product quality.
• Develop new processes as needed for the production of plasma-derived therapies.
• Ensure familiarity with regulatory guidelines for process development and validation and implement necessary manufacturing process changes.
• Optimize and maintain compliance in the PD laboratory by ensuring that all equipment calibration, IQ, OQ, and PM statuses are up to date.
• Participate in the design and planning of scientific experiments to meet corporate goals for existing projects.
• Review and/or approve cGMP documentation generated by other members of the PD group as needed.
• Lead the execution of process development and evaluation studies, as well as process validations using a qualified scale-down model.
• Oversee the transfer of process changes and/or new processes from PD to Manufacturing.
• Act as a liaison between PD and Manufacturing to support deviations, investigations, and process transfers.
• Maintain and review process development batch records for scale-down process models.
• Perform additional activities as assigned by PD Managers.
• Support Manufacturing, Engineering, and Quality Management in the development and implementation of new processes and technologies.
• Assist manufacturing personnel in executing process development and process validation studies within a cGMP production environment.

Qualifications

• Education: Bachelor‚Äôs degree in Science, Engineering, or a related field required.
• Experience: A minimum of 10 years in a cGMP Pharmaceutical/Biological manufacturing environment; strong familiarity with process development and FDA cGMP requirements.

Skills

• Ability to follow cGMPs and procedures with attention to detail.
• Capability to work in a high-pressure, deadline-driven environment.
• Strong goal orientation, problem-solving, and deadline management.
• Effective time management and ability to balance multiple assignments.
• Excellent oral and written communication skills for collaboration with cross-functional teams.

Education

• Bachelor‚Äôs degree in Science, Engineering, or a related field (required).

Additional Requirements

• None beyond those listed in Responsibilities/Qualifications.