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Job Description
The Process Engineer II will play a critical role in bringing our facility into a production-ready state, and in facility and equipment design through commercialization for a newly announced facility expansion for biologics. Scope for the expansion includes a dedicated high-speed cartridge filling line, substantial upgrade to critical utilities services, and dedicated formulation and processing suites with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities. In the project delivery and startup phase of the project (currently in progress through 2025), the Senior Process Engineer will be dynamic as we endeavor to support the startup, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. The Senior Process Engineer 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 successful candidate 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
- You must have a willingness to perform “hands-on” work in a dynamic, team-oriented work setting.
- 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.
Basic Qualifications and Capabilities
- Bachelor’s degree in Engineering required.
- 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.
Preferred
- 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.