Senior Process/Equipment Engineer

Device Assembly & Packaging

Position Summary

ASI is seeking a Senior Process/Equipment Engineer to support the delivery and startup of our client’s device assembly and packaging lines at their expansion of their pharmaceutical manufacturing site located in the Kenosha County Area, WI. In this role, the engineer will serve as an owner’s representative and equipment subject matter expert, coordinating OEMs and cross-functional site teams from design review through FAT, installation, SAT, qualification, ramp-up, and transition to routine operations. The role requires strong packaging or automated assembly equipment experience, practical troubleshooting ability, and the judgment to keep safety, quality, schedule, reliability, and operational readiness aligned during a fast-moving greenfield startup.

Key Responsibilities

•      Own assigned device assembly and packaging systems through design, vendor build, FAT, installation, SAT, commissioning, qualification, startup, and performance ramp-up.

•      Coordinate technical activities among Engineering, Global Packaging & Robotics, OEMs, automation integrators, construction, Quality, Operations, Maintenance, IT, logistics, and validation teams.

•      Review equipment layouts, process flows, specifications, drawings, utilities, guarding, ergonomics, electrical and machine-safety designs, maintainability, and compliance with applicable and regulatory requirements.

•      Support device assembly lines and the seven packaging lines, including cartoners, case packers, pack line modules, checkweighers, labelers, robotic literature loaders, tray unloaders, accumulators, barcode graders, conveyors, robotic palletizers, and stretch wrappers.

•      Verify equipment and facility-interface readiness, including equipment air, vacuum, chilled water, HVAC/BMS points, utilities, calibration, drawings, spare parts, maintenance plans, procedures, and training.

•      Develop or support system overviews, user requirements, design reviews, impact assessments, risk assessments/pFMEAs, action classifications, parameter specifications, alarm rationalization, qualification documentation, and turnover packages as assigned.

•      Lead or support commissioning and qualification execution, discrepancy resolution, punch-list closure, PSSR, safety verification, operational trials, performance qualification, and startup-readiness reviews.

•      Establish equipment operating ranges, critical process parameters, performance indicators, control charts, and monitoring plans; use operating data to improve throughput, yield, reliability, and variability.

•      Lead structured troubleshooting and root-cause investigations for mechanical, process, quality, and integration issues; implement technically robust corrective actions and CAPA commitments.

•      Establish system/component classification, preventive maintenance and reliability strategies, planned downtime needs, spare-parts requirements, and lifecycle ownership expectations.

•      Assess changes for impact to the qualified state and support change controls, deviations, holds, periodic reviews, and continuous-improvement projects.

•      Provide technical direction to engineering technicians, maintenance personnel, vendors, and other project resources supporting assigned lines.

Requirements

Required Qualifications

•      Bachelor’s degree in mechanical, manufacturing, chemical, electrical, biomedical, or another relevant engineering discipline.

•      At least seven years of process, equipment, manufacturing, or project engineering experience supporting highly automated production equipment.

•      Demonstrated experience delivering capital equipment through design review, FAT, installation, SAT, commissioning, qualification, startup, and handover to operations.

•      Working knowledge of automated packaging or assembly equipment, robotics, vision/inspection systems, material handling, controls, and equipment utilities.

•      Experience in a regulated manufacturing environment, including disciplined documentation, change control, deviation/CAPA, and qualification practices.

•      Strong technical leadership, project coordination, troubleshooting, written communication, and cross-functional collaboration skills.

•      Ability to travel domestically or internationally to OEM facilities and provide flexible startup support when needed.

Preferred Experience

•      Pharmaceutical or medical-device cGMP manufacturing and familiarity with 21 CFR requirements.

•      High-speed secondary packaging, combination-product device assembly, serialization, robotics, vision inspection, or automated palletization.

•      Risk-based commissioning and qualification, including URS, DQ/design review, FAT/SAT, IQ/OQ or IV/OV, pFMEA/CRMA, and qualification summary documentation.

•      Experience supporting a greenfield facility startup or major brownfield expansion.