Senior Process/Equipment Engineer

Automated Systems, Inc.; Kenosha (WI); On-site; USD 110,000 - 140,000; Full time

Job summary

Automated Systems, Inc. (ASI) seeks a Senior Process/Equipment Engineer to support the delivery and startup of device assembly and packaging lines at a pharmaceutical manufacturing expansion in Kenosha County, WI.

The engineer acts as an owner’s representative and equipment SME, coordinating OEMs and site teams from design review through FAT, SAT, qualification, ramp-up, and transition to operations. The role requires strong packaging or automated assembly equipment experience, practical

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.

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 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.

Skills

Packaging equipment experience

Automation & robotics knowledge

Project leadership

Troubleshooting

Cross-functional collaboration

Regulated manufacturing experience

Education

Bachelor's degree in mechanical, manufacturing, chemical, electrical, biomedical or related engineering

Job description

Kenosha, United States | Posted on 09/08/2026

• Industry Pharma/Biotech/Clinical Research
• Work Experience 5+ years
• State/Province Wisconsin
• Country United States

Job Description

Device Assembly & Packaging

Engagement

Contract assignment through Automated Systems,Inc. (ASI)

Schedule

Monday-Friday; startup and rotational on-callsupport may be required

Travel

Approximately 25-50% during vendor build/FAT andstartup; lower after operational readiness

Position Summary

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

Key Responsibilities

• Own assigned device assembly and packagingsystems 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 andmachine-safety designs, maintainability, and compliance with applicable andregulatory requirements.
• Support device assembly lines and the sevenpackaging lines, including cartoners, case packers, pack line modules,checkweighers, labelers, robotic literature loaders, tray unloaders,accumulators, barcode graders, conveyors, robotic palletizers, and stretchwrappers.
• Verify equipment and facility-interfacereadiness, including equipment air, vacuum, chilled water, HVAC/BMS points,utilities, calibration, drawings, spare parts, maintenance plans, procedures,and training.
• Develop or support system overviews, userrequirements, 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 qualificationexecution, discrepancy resolution, punch-list closure, PSSR, safetyverification, operational trials, performance qualification, andstartup-readiness reviews.
• Establish equipment operating ranges, criticalprocess parameters, performance indicators, control charts, and monitoringplans; use operating data to improve throughput, yield, reliability, andvariability.
• Lead structured troubleshooting and root-causeinvestigations 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 stateand support change controls, deviations, holds, periodic reviews, andcontinuous-improvement projects.
• Provide technical direction to engineeringtechnicians, maintenance personnel, vendors, and other project resourcessupporting 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 automatedproduction equipment.
• Demonstrated experience delivering capitalequipment through design review, FAT, installation, SAT, commissioning,qualification, startup, and handover to operations.
• Working knowledge of automated packaging orassembly equipment, robotics, vision/inspection systems, material handling,controls, and equipment utilities.
• Experience in a regulated manufacturingenvironment, including disciplined documentation, change control,deviation/CAPA, and qualification practices.
• Strong technical leadership, projectcoordination, troubleshooting, written communication, and cross-functionalcollaboration skills.
• Ability to travel domestically orinternationally to OEM facilities and provide flexible startup support whenneeded.

Preferred Experience

• Pharmaceutical or medical-device cGMPmanufacturing and familiarity with 21 CFR requirements.
• High-speed secondary packaging,combination-product device assembly, serialization, robotics, visioninspection, or automated palletization.
• Risk-based commissioning and qualification,including URS, DQ/design review, FAT/SAT, IQ/OQ or IV/OV, pFMEA/CRMA, andqualification summary documentation.
• Experience supporting a greenfield facilitystartup or major brownfield expansion.