Sr. Principal Engineer

Fresenius Kabi USA; Wilson (NC); On-site; USD 91,000 - 127,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holiday and personal/fk

Health benefits: medical, prescription

Dental and vision coverage

Life insurance

Disability

Wellness program

Job summary

Fresenius Kabi USA is seeking a senior engineering professional to lead the design, development, implementation and support of automation, electrical control systems, equipment, and facilities. The role acts as a technical lead within Engineering and collaborates with Maintenance and Validation to meet regulatory and policy requirements.

You will drive improvements to plant efficiency and capacity through modernization, validation, and risk-based documentation across projects and operations.

Responsibilities

• Develop, implement and support automated packaging and PLC/HMI systems.
• Maintain and improve complex production and packaging processes in a cGMP/data integrity compliant state.
• Lead capital improvement projects from funding requests through installation and testing.
• Provide technical leadership to engineering, maintenance and validation teams.

Job description

Job Summary

Leads the design, development, implementation and support of all aspects of automation, electrical control systems, equipment, and machinery related to site utilities, production equipment, and facilities. Is a technical leader and subject matter expert within Engineering, and a resource to the Maintenance and Validation departments to meet all regulatory and company specific policy requirements and to improve plant efficiency, capacity, and capability via continuous improvement and modernization objectives.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Responsible for the research, development, design, layout, building, testing, troubleshooting, repairs and improvement of all manufacturing equipment.
• Responsible for the development, implementation, and technical support/ for all automated packaging and associated Programmable Logic Controllers (PLC), Human-Machine-Interfaces (HMI), and server/industrial IT network infrastructure.
• Responsible for implementing and maintaining complex production and packaging systems in a compliant (cGMP/data integrity) validated and operational state including calibration, maintenance, repairs, and hardware/software updates.
• Guides the conceptualization and development of new methodologies, processes, materials, machines, and computerized equipment for a pharmaceutical production environment.
• Generates innovative solutions to complex problems through the use of multiple disciplines and technical principles and advises senior management regarding appropriate action.
• Responsible for developing and implementing improvements for efficiency, safety and preventing equipment obsolescence. Leads capital improvement projects, including: funding requests, acquisition, installation, startup and associated documentation (including Risk Assessments, User Requirement Specifications, Functional Requirement Specifications, Design Specifications/Qualifications, Factory and Site Acceptance Tests, Machinability Studies and Standard Operating Procedures), and other items deemed appropriate by management.
• Responsible for rebuilding and upgrading of site utility systems and production equipment associated with packaging, and warehousing/distribution areas.
• Responsible for ensuring the validated state of all equipment, systems and facilities and compliance with all applicable cGMP (including data integrity), OSHA, DEC, EPA, ISO and local government regulations.
• Responsible for developing relationships with key vendors for technical support and for assistance in hardware applications. Networks with key contacts outside own area of expertise.
• Works without supervision on highly complex projects with extensive latitude for independent judgement.
• May supervise 3-5 direct reports. Acts as advisor to the engineering team, project teams, and plant management to meet schedules and budgets and/or resolve complex technical issues. May manage the work efforts of supervisors

Salary Range: $90,816 - $126,991

Position is eligible to participate in a bonus plan with a target of 10% of the base salary.

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Additional Information

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.