Project Engineer

Technical Source is supporting a leading biopharmaceutical client in Raritan, NJ in the search for an Operations Readiness Project Engineer. This role will sit onsite within the client’s engineering/CQV team and support multiple biologics and cell therapy projects through late-stage commissioning, qualification, validation (CQV), and operational startup. You will be a key link between Engineering, CQV, Manufacturing, Quality, and Facilities—ensuring that systems, equipment, procedures, and people are fully prepared for compliant, on-time operations. Key Responsibilities Support operations readiness planning and execution across commissioning, qualification, validation, manufacturing, and quality functions for multiple projects. Coordinate readiness activities across Engineering, CQV, Manufacturing, Quality, and Facilities to ensure seamless handover into routine operations. Contribute to and help maintain integrated project schedules, including CQV milestones, interdependencies, and resource constraints. Identify, track, and help mitigate project and operational readiness risks, supporting contingency and recovery planning when needed. Coordinate and oversee aspects of CQV readiness, ensuring systems and equipment are prepared to meet regulatory and operational requirements. Support management of scope changes and assess readiness impacts to maintain original project and startup objectives. Develop or support cost estimates and forecasts related to readiness activities (labor, vendor support, and supporting services). Prepare and deliver project status reports, dashboards, and presentations for project stakeholders. Act as a day-to-day interface between cross-functional teams, helping drive decisions and alignment in a cGMP environment. Facilitate or support readiness reviews, risk workshops, and cross-functional meetings focused on startup and operational handover. Adhere to client governance, documentation, and reporting standards in a highly regulated environment. Required Qualifications Education: Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline (or equivalent experience). Experience: 3–7 years of project engineering, project management, CQV, or operations readiness experience in pharmaceutical or biopharmaceutical manufacturing environments. Proven experience supporting operations readiness, startup, or late-stage project delivery, ideally across multiple workstreams. Strong understanding of the commissioning, qualification, and validation (CQV) lifecycle and how it integrates with manufacturing and operational readiness. Solid knowledge of cGMP requirements, engineering lifecycles, and pharmaceutical quality systems. Demonstrated ability to work cross-functionally with engineering, manufacturing, quality, and facilities/maintenance teams. Experience coordinating vendors, contractors, and internal stakeholders to deliver scope on time and within budget. Strong communication, stakeholder management, and decision-making skills. Experience facilitating or actively participating in meetings and driving alignment in regulated environments. Preferred Qualifications Experience in biologics and/or cell therapy manufacturing environments (upstream, downstream, or aseptic operations). Previous involvement in facility or line startup projects, tech transfer, or late-stage capex projects. Familiarity with ISPE Good Practice Guides and structured project management methodologies. Hands‑on experience with project scheduling and reporting tools (e.g., MS Project, Primavera, Smartsheet, Power BI, or similar). Experience in a consulting or embedded role within a large pharma/biotech organization. Soft Skills & Attributes Strong organizational skills and attention to detail, able to manage multiple projects and priorities in parallel. Proactive, resourceful, and comfortable working in a dynamic, fast‑paced environment. Able to influence without formal authority and build strong working relationships with diverse teams. Comfortable working 100% onsite in a highly regulated manufacturing setting. #J-18808-Ljbffr