Process Engineer, Biologics

Civica - Petersburg, VA

Full-time - Mid Level

Petersburg, VA

51-100 employees

Professional, Scientific, and Technical Services

About the position

The Process Engineer, Biologics will be instrumental in preparing the Civica Petersburg, VA facility for production and in the design of equipment and facilities for a new biologics expansion. This role involves collaboration with various departments to develop and improve technical transfer processes, ensuring compliance with regulatory standards and supporting the startup of GMP operations. The position requires hands-on work and a proactive approach to problem-solving as the facility transitions to full-scale manufacturing.

Responsibilities

• Provide technical expertise on CQV activities and ensure compliance with regulatory requirements, industry best practices, and Engineering standards.
• Participate directly in the Engineering process to develop and institute technical and procedural controls in the process design.
• Develop the manufacturing process, considering scale-up factors and calculations, and design scale-up/engineering batches to optimize the manufacturing process.
• Support all CQV activity for assigned systems, including all phases: identifying user requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.
• Execute Engineering deliverables in a timely manner, planning and proactively pursuing details and elevating risks appropriately to ensure project completion without avoidable delays.
• Anticipate operational gaps (improvements to facility/equipment design, process inefficiencies, job hazards) to ensure a smoother transition to the Manufacturing team.
• Lead and participate in cross-functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
• Build control strategy documents, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D.
• Provide technical support to manufacturing teams at various stages of operations starting from compounding, filtrations, fill and finish, terminal sterilization, and autoclave processes.
• Troubleshoot and resolve any technical issues that arise on the manufacturing floor.

Requirements

• Bachelor of Science in Pharmaceutical Sciences, Engineering, or a similar technical degree.
• Strong mechanical aptitude with a minimum of 3 years related industry experience, preferably in Sterile Fill Finish, biologics, and material handling.
• Familiarity with scale-up factors and design of process scale-up studies.
• Experience working in an FDA regulated environment.
• Demonstrated ability to solve technical problems and implement projects.
• Excellent interpersonal and communication skills, and fluency in English.
• Self-directed with effective analytical and problem-solving skills.
• Ability to deliver results on multiple complex assignments simultaneously in a fast-paced environment.
• Ability to interact well with other functions (e.g., Manufacturing, Automation, Quality Assurance, R&D) and take ownership of assigned projects with minimal direction.
• Willingness to adapt to changing priorities as project demands change.

Nice-to-haves

• 3+ years of experience in sterile injectables, drug-device combination products, or biologics.
• SME-level knowledge of drug product and material handling.
• Direct experience ordering capital equipment, materials required for production, spare parts, and calibration and maintenance services.
• Familiarity with cleaning validation and/or process validation.
• Previous work at greenfield sites or substantial facility expansion projects.