Senior Risk Analyst Jobs in Dover, DE (NOW HIRING)

• Serve as the site technical design authority for OSD manufacturing and packaging equipment, ensuring that process equipment, facility design, utilities, controls, containment, material flow, and operator access function together as an operable, safe, and maintainable system.
• Review and approve equipment layouts, general-arrangement drawings, 3D models, stack-up studies, P&IDs, utility requirements, connection-point data, operating envelopes, structural loads, access platforms, lifting concepts, maintenance clearances, and cleaning provisions.
• Translate user, process, and operational requirements into clear engineering criteria, technical specifications, and design decisions; identify gaps between vendor equipment designs and facility capabilities before installation or start-up.
• Lead multidisciplinary design reviews and resolve interface gaps among the architectural and engineering firm, construction management team, equipment vendors, installation contractors, automation, CQV, Quality, EHS, Operations, and Maintenance.
• Evaluate proposed equipment and facility modifications for cGMP impact, safety, containment, cleanability, maintainability, constructability, capacity, cost, schedule, and future operational flexibility.
• Own or lead resolution of critical field RFIs, design clarifications, installation conflicts, and technical deviations, and ensure approved solutions are reflected in final drawings and as-built documentation.

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

• 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, corrective and preventive actions, and recurring equipment-performance investigations involving multiple disciplines or vendors.
• Develop engineering solutions for major modifications, equipment replacement, capacity expansion, new product introductions, technology transfers, and future facility upgrades.
• Assess facility and equipment impact for proposed changes, including space, utilities, automation, structural loading, containment, cleaning, material and personnel flow, access, and maintainability requirements.
• Partner with Maintenance and Reliability to define equipment lifecycle strategies, critical-spare requirements, obsolescence plans, reliability improvements, and vendor technical-support models.
• Support change controls and ensure that drawings, specifications, equipment files, system boundaries, and as-built documentation remain accurate throughout the equipment lifecycle.
• Lead or support continuous-improvement initiatives that improve safety, compliance, reliability, throughput, changeover, cleaning, and total cost of ownership.
• Maintain effective technical relationships with equipment manufacturers, design firms, specialty consultants, and service providers while building sufficient internal capability to reduce long-term dependence on external design support.

• Bachelor's degree in Chemical, Mechanical, Pharmaceutical, or related Engineering discipline with 12+ years of relevant pharmaceutical engineering experience; Master's degree with 10+ years; or Ph.D. 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, equipment specifications, 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, communicate recommendations clearly, and work effectively with internal teams, design firms, contractors, and equipment vendors.

Preferred Qualifications:

• Experience in a CDMO/CMO environment supporting multiple products, clients, or rapidly changing project priorities.
• Experience with high-containment equipment and OEB3/OEB4 applications, material-handling systems, IBC/bin systems, lifting devices, granulation, compression, encapsulation, coating, or packaging equipment.
• Working knowledge of process automation, equipment controls, data interfaces, serialization, computerized systems, and their integration with facility and quality-system requirements.
• Professional Engineer (PE), Project Management Professional (PMP), Lean Six Sigma, or other relevant professional certification is desirable.
• Prior experience supporting regulatory inspections, operational readiness, and post-start-up technical services in a pharmaceutical manufacturing facility.