Technical Engineering Lead, Boxborough

Job description

Job Summary The Engineering Lead will be responsible for leading the review, development, and integration of engineering requirements for manufacturing equipment and facilities within a cGMP biopharmaceutical environment. This role partners closely with MSAT, Manufacturing, Facilities, Automation, and external vendors to ensure equipment is designed, installed, commissioned, qualified, and maintained to support operational excellence. The Engineering Lead will also provide technical leadership, mentor engineering staff, and drive continuous improvement initiatives across manufacturing systems. Essential Job Functions • Lead the review and integration of engineering, customer, and MSAT requirements into equipment specifications, layouts, and acceptance criteria. • Participate in design reviews and manage engineering changes, RFIs, and technical documentation. • Coordinate equipment utilities, automation, controls, and data interfaces with cross-functional partners. • Support FAT, SAT, commissioning, qualification, and startup activities. • Own equipment performance, reliability, and lifecycle management. • Lead troubleshooting and root cause investigations. • Drive continuous improvement in equipment performance and uptime. • Support technology transfers, PPQ, and engineering runs. • Manage technical assessments, upgrades, and change controls. • Develop lifecycle plans, budgets, and capital projects. • Mentor and develop engineering staff. Education Bachelor's degree in Biological Engineering, Chemical Engineering, Mechanical Engineering, or a related STEM discipline required. Experience and Skills • Minimum 7 years of engineering experience within a biopharmaceutical or biotechnology manufacturing environment. • Proven experience leading engineering projects in a cGMP-regulated environment. • Experience supporting manufacturing equipment lifecycle management and qualification. • Direct experience with fill/finish isolator systems and lyophilization preferred. • Experience supporting large-scale capital projects preferred. • Strong troubleshooting and problem-solving abilities. • Excellent collaboration and communication skills. • Demonstrated leadership and mentoring experience. Base annual sarlary range $165,000 to $180,000 Apply