Jobs at Fresenius Kabi

The Principal Electrical Engineer designs and develops electrical systems, builds prototypes, conducts failure analysis, and collaborates with teams to optimize product performance.

Leads QA compliance and continuous improvement projects supporting GMP quality systems and finished-product release. Manages project plans, metrics, CAPAs, deviations, yield and batch-release improvements, root-cause reviews, corrective actions, reporting, and risk escalation. Analyzes quality and manufacturing data, supports FDA inspections and audits, develops contingency plans, and presents progress to senior management.

Leads site-wide aseptic training, personnel qualification, contamination control, and continuous improvement across sterile manufacturing operations. Manages aseptic mentors and training personnel, establishes performance metrics, oversees gowning and media-fill qualification programs, investigates contamination-related events and CAPAs, and supports regulatory inspections. Partners with Production, Quality, Validation, Engineering, and Maintenance to standardize aseptic practices, improve operational performance, maintain compliance, and prepare the facility for new sterile manufacturing lines and products.

Weighs and mixes chemical compounds for pharmaceutical product formulation and filling. Operates and monitors tanks, mixing equipment, PCS7 controls, scales, pH meters, and WFI systems. Adjusts product pH, samples batches, sanitizes equipment, documents manufacturing and cleaning activities, follows cGMP and SOP requirements, maintains raw materials, initiates work orders, and supports employee training and continuous improvement.

Weighs and mixes chemical compounds for pharmaceutical formulation and filling. Operates tanks, mixing equipment, PCS7 recipe controls, scales, pH meters, and WFI systems. Monitors product quality, adjusts pH, samples batches, cleans and sanitizes equipment, records manufacturing documentation, follows cGMP and SOP requirements, initiates maintenance work orders, supports continuous improvement, and trains new employees.

Provides daily direction to 10–20 manufacturing associates, ensuring cGMP, safety, quality, and production compliance. Coordinates scheduling, cleaning, sampling, documentation, training, equipment and facility work orders, batch record reconciliation, SAP transactions, investigations, and continuous improvement projects. Collaborates with quality, laboratory, engineering, validation, and production planning teams to maintain efficient and compliant manufacturing operations.

Performs routine chemical testing of raw materials, in-process samples, stability samples, and finished products for Quality Control. Documents results according to Good Documentation Practices and cGMP or GLP requirements, maintains project records, updates controlled documents in Documentum, conducts peer data reviews, follows safety and housekeeping procedures, and communicates findings to management and peers.

Leads quality assurance projects focused on pharmaceutical GMP compliance, continuous improvement, deviation and CAPA reduction, batch release efficiency, quality metrics, root-cause analysis, and audit readiness. Provides PMO oversight, coordinates cross-functional teams, reviews investigations and corrective actions, and supports microbiology and sterility assurance activities including contamination control, aseptic processing, media fills, and isolator technology.

Administers customer contracts for medical devices, including pricing, compliance, rebates, reporting, amendments, approvals, and renewals. Collaborates with Commercial, Finance, and Legal teams on contract development and customer requests. Maintains contract records and ERP pricing data, resolves pricing disputes, processes orders and returns, manages deadlines and billing obligations, and supports process improvements. The role is hybrid, requiring onsite work in Lake Zurich, Illinois, three days per week.

Administers customer contracts for medical devices, including pricing, rebates, compliance, amendments, reporting, renewals, and payment terms. Collaborates with Commercial, Finance, and Legal teams, resolves pricing disputes, maintains contract records and ERP master data, processes orders and returns, manages deadlines, and supports process improvements. The role requires strong analytical, organizational, communication, and cross-functional collaboration skills, along with SAP or comparable ERP experience and proficiency in Word and Excel.

Coordinates daily medical device service depot operations, including device receipt, testing, returns, packaging, shipping, work-order execution, resource allocation, and shift priorities. Supports technician training, quality documentation, audits, and compliance with cGMP, FDA, ISO 13485, and internal standards. Monitors performance metrics, escalates technical issues, drives continuous improvement, and maintains efficient, compliant depot operations.

Calibrates, inspects, tests, maintains, and repairs instruments, meters, gauges, and other measuring equipment. Uses specialized tools, procedures, software, calculations, and numerical data to ensure equipment accuracy, precision, reliability, and compliance with industry standards in pharmaceutical and medical device environments. Documents calibration activities, identifies equipment issues, supports repairs and upgrades, communicates results, and completes assignments on schedule.

Leads the U.S. pharmacovigilance and FDA compliance program across multiple product areas. Oversees adverse-event intake, assessment, reporting, signal management, literature reviews, audits, quality planning, safety agreements, and regulatory readiness. Advises global committees and cross-functional teams on labeling, recalls, and product safety. Manages budgets, develops policies and SOPs, and leads, mentors, and develops a multidisciplinary vigilance organization.

Ensures manufactured products meet defined quality and regulatory standards by establishing quality processes, maintaining quality systems, auditing manufacturing operations, monitoring outputs, and investigating process deviations and finished-goods defects.

Oversees engineering project execution, including design, specifications, scheduling, cost estimation, resource coordination, production, installation, testing, and commissioning. Monitors progress against project plans, resolves operational issues, minimizes delays, and develops required resources. May also establish engineering standards, prepare budgets and forecasts, select materials and equipment, and coordinate project staff and external contractors.

Ensures manufactured materials and products meet defined quality and regulatory standards. Develops quality processes and supporting infrastructure, audits manufacturing operations, monitors outputs, and investigates or reports process deviations and finished-product defects.

Assembles, operates, and monitors aseptic manufacturing equipment according to SOPs and cGMP requirements. Applies aseptic techniques to minimize contamination and uses computerized HMI systems. Also supports data entry, office events and moves, reception or mailroom coverage, office systems and procedures, and coordination with corporate entities, vendors, and suppliers.

Provides strategic and generalist HR support, including employee relations, investigations, policy administration, recruiting, compensation, benefits, compliance reporting, organizational design, performance management, training, HRIS support, payroll coordination, employee engagement, and workers’ compensation oversight. The role partners with managers across the organization and may supervise HR staff. It requires onsite work in Lake Zurich three days weekly, with remote work permitted on remaining days.

Provides quality oversight for QC metrology, technology transfer, chemistry, and microbiology laboratories. Reviews and approves validation protocols, investigations, batch records, deviations, OOS/OOT results, and change controls. Supports the Empower network and laboratory computer systems, including hardware and software installation, troubleshooting, user support, audit trail reviews, system compliance audits, upgrades, and documentation under cGMP requirements.

Leads U.S. revenue accounting, gross-to-net accounting, IFRS 15 compliance, internal controls, SAP GRC governance, audits, and financial reporting for a multinational life sciences business. Oversees control frameworks across major financial processes, evaluates complex commercial arrangements, improves systems and processes, presents risks and recommendations to executive leadership, and develops revenue accounting and internal controls teams.