Process Engineer II

Job Description

The Process Engineer II will play a critical role in bringing our client’s facility into a production-ready state including facility and equipment design through commercialization for a newly announced facility expansion for biologics. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

The Process Engineer II will act as a bridge between the project planning phase and ongoing operations by assuming system owner responsibility for one or more manufacturing systems. In this role, the professional will work closely with validation, manufacturing, and quality assurance to ensure availability, support, and maintenance of those system(s) throughout their lifecycle and serve as subject matter expert internally and in regulatory inspections for production processes utilizing those systems.

Essential Duties and 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.
• Ability to anticipate operational gaps (improvements to facility/equipment design, process inefficiencies, job hazards).
• 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.

Basic Qualifications and Capabilities

• Bachelor’s degree in engineering required.
• 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.
• 5+ years of experience in sterile injectables, drug-device combination products, or biologics.
• 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.