Process Engineer II (238)

About the role

The Process Engineer II will play a critical role in bringing the Civica Petersburg, VA facility into a production-ready state, and in facility and equipment design through commercialization for a newly announced facility expansion for biologics.

Responsibilities

• Provide technical expertise on CQV activities and ensures compliance to 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.
• Accountable for 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) rather than scrambling to fix issues in the project startup, leading to a smoother and safer 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.
• Interpersonal skills to manage interactions and drive results across a range of business functions, education levels, and cultural backgrounds within the site. Extends to external communication with system vendors.

Requirements

• Willingness to perform "hands-on" work in a dynamic, team-oriented work setting.
• Strong mechanical aptitude.
• 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. Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment.
• Interact well with other functions (e.g. Manufacturing, Automation, Quality Assurance, R&D) and must be able to take ownership of and follow through on assigned projects with minimal required direction from his/her supervisor.
• Willingness to adapt to changing priorities as project demands change.

Qualifications

• Bachelor’s degree in Engineering required.
• 5+ years of experience in sterile injectables, drug-device combination products, or biologics preferred.
• SME-level knowledge of drug product processing equipment (e.g. single-use mixers and stainless steel formulation vessels, parts washers, autoclaves, component processors, aseptic filling equipment – vials, pre-filled syringes, and cartridges – isolators with VPHP decontamination, filter integrity and isolator glove integrity testers).
• 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 preferred.