Senior Manufacturing Engineer

We are seeking a Engineer to serve as the site technical authority for oral solid dosage (OSD) manufacturing and packaging equipment. This individual will ensure that process equipment, facility design, utilities, controls, containment, material flow, and operator access function together as a safe, compliant, and maintainable system; from initial design through the full equipment lifecycle. The role spans capital project execution, equipment installation and qualification, and ongoing operational technical support.

Responsibilities:

Equipment design & integration

• Serve as site technical design authority for OSD manufacturing and packaging equipment across process, facility, utility, controls, containment, and material flow interfaces
• Review and approve equipment layouts, general-arrangement drawings, 3D models, P&IDs, utility requirements, structural loads, access platforms, maintenance clearances, and cleaning provisions
• Translate user, process, and operational requirements into engineering criteria, technical specifications, and design decisions; identify gaps between vendor equipment designs and facility capabilities prior to installation
• Lead multidisciplinary design reviews and resolve interface gaps among architectural and engineering firms, construction management, equipment vendors, installation contractors, automation, CQV, Quality, EHS, Operations, and Maintenance
• Evaluate proposed equipment and facility modifications for cGMP impact, safety, containment, cleanability, maintainability, capacity, cost, schedule, and operational flexibility
• Own or lead resolution of critical field RFIs, design clarifications, installation conflicts, and technical deviations; ensure approved solutions are reflected in final drawings and as-built documentation

Project, start-up & qualification support

• Provide senior technical oversight during vendor design, FAT, SAT, equipment installation, commissioning, qualification, and handover with emphasis on integrated system functionality
• Conduct engineering risk assessments, option analyses, and cost/schedule trade-off evaluations; present technically supported recommendations to site and project leadership
• Confirm that vendor and contractor technical deliverables are complete, coordinated, and suitable for installation, operation, maintenance, and future change control
• Establish and maintain site engineering standards, equipment-integration checklists, design-review practices, and technical documentation expectations
• Provide technical leadership and mentoring to equipment engineers and project team members; support development of internal site engineering capability

Lifecycle technical services

• Remain the site technical authority for assigned process equipment and integrated manufacturing systems after handover to Operations
• Lead complex troubleshooting, root-cause investigations, deviation support, CAPA activities, and recurring equipment-performance investigations
• Develop engineering solutions for major modifications, equipment replacement, capacity expansion, new product introductions, technology transfers, and facility upgrades
• Partner with Maintenance and Reliability to define lifecycle strategies, critical-spare requirements, obsolescence plans, and vendor technical-support models
• Support change controls and ensure drawings, specifications, equipment files, and as-built documentation remain accurate throughout the equipment lifecycle
• Lead or support continuous-improvement initiatives targeting safety, compliance, reliability, throughput, changeover, cleaning, and total cost of ownership

Required Qualifications:

Education & Experience

• Bachelor's degree in Chemical, Mechanical, Pharmaceutical, or related Engineering with 12 years of relevant pharmaceutical engineering experience; Master's with 10 years; or PhD with 8 years
• Extensive experience with pharmaceutical drug-product process equipment and equipment-to-facility integration, preferably including OSD manufacturing and packaging systems
• Demonstrated experience supporting greenfield facilities, major capital projects, equipment installation, commissioning, qualification, start-up, or significant facility expansions
• Strong experience reviewing and coordinating layouts, general-arrangement drawings, 3D models, P&IDs, utility interfaces, and multidisciplinary engineering deliverables
• In-depth understanding of cGMP engineering practices, design control, change control, equipment lifecycle documentation, and applicable regulatory expectations
• Proven ability to lead cross-functional technical decisions, resolve complex problems, and work effectively with internal teams, design firms, contractors, and equipment vendors