Job Description The Project Engineer will serve as a key technical and project-focused contributor supporting New Product Introductions (NPI), equipment qualification, and operational excellence initiatives within biopharmaceutical manufacturing—specifically in the monoclonal antibody (mAb) space. This role blends engineering rigor with project controls, scheduling expertise, and cross-functional coordination to drive efficient, compliant, and scalable implementation of processes, technologies, and equipment. The ideal candidate possesses deep understanding of bioprocess unit operations, strong analytical and project management capability, and the ability to develop structured workflows, charters, and resource-driven schedules. Key Responsibilities 1. Project Controls, Scheduling & Execution Build and manage detailed project schedules using Microsoft Project / Power Project, including dependencies, durations, resource loading, and critical path analysis. Develop comprehensive project charters that define scope, timeline, roles, risks, and deliverables. Analyze raw project data to interpret trends, generate progress reports, and optimize resource utilization. Drive alignment on cross-functional activities and ensure schedules reflect realistic sequencing and capacity constraints. Identify and mitigate bottlenecks to accelerate project delivery. 2. New Product Introduction (NPI) & Equipment Qualification Develop and execute plans for the introduction of new products, equipment, and technologies. Support and coordinate equipment qualification activities (IQ/OQ/PQ) and change control documentation. Ensure integration of new assets and processes aligns with GMP, quality, regulatory, and safety expectations. Partner with operations, quality, and validation teams to ensure readiness for tech transfer and startup. 3. Process Engineering & Biopharma Technical Expertise Provide engineering support for upstream and downstream unit operations including: Bioreactors (single-use and stainless steel),,Chromatography systems , Filtration technologies (UF/DF, TFF, depth filtration), Buffer and media preparation, General large-molecule manufacturing workflows Utilize understanding of biologics manufacturing principles to support troubleshooting, optimization, and process fit assessments. Collaborate with R&D and MS&T teams on technology transfer and process scale-up. 4. Operational Excellence & Process Optimization Analyze non-critical paths to condense, parallelize, and streamline activities across calibration, QC testing, validation, and operational support. Develop data-driven insights and visualizations to drive decision-making and continuous improvement. Create standardized work templates and best-practice workflows to improve consistency and reduce inefficiency. Lead or support structured problem-solving efforts (root cause analysis, SWAT issue response, etc.). 5. Stakeholder Management & Communication Coordinate updates, deliverables, and alignment across operations, engineering, quality, supply chain, and finance. Prepare clear communication plans, dashboards, and project roadmaps. Facilitate meetings to address risks, gaps, and required decisions. Support change management activities and ensure transparent project execution. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements Bachelor’s degree in Engineering (Chemical, Mechanical, Bioprocess, or related field). 5–10+ years of experience in biopharmaceutical, biotech, or life sciences engineering roles. Hands-on experience with monoclonal antibody manufacturing unit operations. Strong proficiency in project scheduling tools (Microsoft Project, Power Project, or equivalent). Demonstrated ability to develop project plans, charters, risk assessments, and resource-loaded schedules. Experience supporting NPI, tech transfer, equipment qualification, or process validation. Proficiency in data analysis and visualization tools (Power BI, Excel, etc.). Strong analytical, communication, and cross-functional leadership capabilities. Advanced degree (MS/PhD) in a related engineering or life sciences discipline. Lean, Six Sigma, or operational excellence certification. Experience with MES, digital tools, or electronic systems used in GMP manufacturing. PMP, Agile, or similar project management certification.